Automated heart valve manufacturing devices and methods

ABSTRACT

An automated system that can be used for prosthetic heart valve manufacturing or suturing procedures. The system can include a first automated fixture that includes an articulating arm and a target device holder. The system can also include one or more additional automated fixtures, which can be configured as one or more suturing arms that include another articulating arm and a needle holder. The first automated fixture can be configured to rotate a target device held by the holder to allow the one or more additional automated fixtures to perform operations such as form sutures on the target device without intervention of a human operator. The system can include a targeting system configured to provide positioning feedback to the system.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.17/179,111, filed Feb. 18, 2021, which is a continuation ofInternational Application No. PCT/US2019/047640 filed Aug. 22, 2019 andentitled “AUTOMATED HEART VALVE MANUFACTURING DEVICES AND METHODS,”which claims the benefit of priority to U.S. Provisional Application No.62/721,404, entitled “AUTOMATED HEART VALVE MANUFACTURING DEVICES ANDMETHODS,” filed Aug. 22, 2018, the entire contents of each of which isexpressly incorporated by reference herein for all purposes.

FIELD

The present disclosure generally relates to the field of heart valvemanufacturing and associated systems, devices, and methods, includingheart valve suturing systems, devices, and methods.

BACKGROUND

Manufacturing prosthetic heart valves and other human prosthetic implantdevices may require suturing, treatment, inspection, etc. of certainportions and/or components thereof. Accuracy and/or efficiency inexecution of suturing operations or other operations for such devicescan be important. Furthermore, it would be beneficial to reduce thepossibility of operator strain that might arise under certain heartvalve suturing operations or other operations.

SUMMARY

This summary is meant to provide some examples and is not intended to belimiting of the scope of the invention in any way. For example, anyfeature included in an example of this summary is not required by theclaims, unless the claims explicitly recite the features. Also, thefeatures, steps, concepts, etc. described in examples in this summaryand elsewhere in this disclosure can be combined in a variety of ways.The description herein relates to devices, apparatuses, systems,assemblies, methods, combinations, etc. that can be utilized formanufacturing and processing heart valves and/or associated or relatedcomponents, devices, apparatuses, etc. Among other features, these orelements of these can utilize or include logic that may receive a set ofparameters as input. In some embodiments, the set of parameters may begraphically displayed to a user after the parameters have been receivedas input. In some embodiments, the set of parameters may be analyzed andnew data generated. In some embodiments, the newly generated data may begraphically displayed to a user after the parameters have been receivedas input.

In some implementations, the present disclosure relates to a method ofmanufacturing a target device or component (e.g., to a method ofmanufacturing, or suturing, a prosthetic implant device, prosthetichuman implant device, prosthetic heart valve, prosthetic human heartvalve, etc.). The method can comprise disposing the target device (e.g.,prosthetic human implant device, etc.) on a holder component of anautomated fixture (e.g., an automated suture fixture). The method canalso comprise directing or providing input to cause the automatedfixture (e.g., automated suture fixture) to position the target device(e.g., prosthetic human implant device, etc.) in a first position,executing a first operation/procedure (e.g., a stitch, inspection, otheroperation/procedure) on the target device (e.g., prosthetic humanimplant device, etc.) using a first hand of the operator, directing orproviding input to cause the automated fixture (e.g., automated suturefixture) to position the target device (e.g., prosthetic human implantdevice, etc.) in a second position, and executing a secondoperation/procedure (e.g., stitch, inspection, etc.) on the targetdevice (e.g., prosthetic human implant device, etc.) using the firsthand of the operator. The target device can be a prosthetic humanimplant device. The prosthetic human implant device can be a heart valveor other type of implant device.

The step of directing or providing input to cause the automated fixture(e.g., automated suture fixture) to position the target device (e.g.,prosthetic human implant device, etc.) in the first position can involvedirecting or providing input to cause the automated fixture (e.g.,automated suture fixture) to move the target device (e.g., prosthetichuman implant device) to a desired focal length from a visualization orimaging system (e.g., a camera lens of an imaging system/camera, etc.).The method can also comprise directing or providing input to cause theautomated fixture (e.g., automated suture fixture) to move or rotate(e.g., rotate; circumferentially rotate; flip; rotate with respect to anaxis, such as an axis that passes through a center point of the device;etc.) the target device (e.g., prosthetic human implant device, etc.) inplace, while maintaining at least some portion of an outer surface ofthe prosthetic human implant device in focus of a visualization orimaging system (e.g., a camera, etc.). This can be done with or withoutmoving the visualization system (e.g., without moving a camera or cameralens). Operation of the automated fixture (e.g., automated suturefixture) can provide for reduced physical strain on the operator, e.g.,it can replicate and/or remove the need for the operator to bend, twist,turn, etc. one hand to move the target device into place for anoperation/procedure (e.g., for suturing, etc.).

The method can further comprise loading a procedure script (e.g., apre-programmed suturing procedure script, suturing script, inspectionscript, other procedure script, etc.) using one or more processorsconfigured to at least partially control the automated fixture (e.g.,automated suture fixture). The method can comprise performing apre-punch on the target device (e.g., prosthetic human implant device,etc.) using a handheld tool operated by a second hand of the operator,e.g., if the automated fixture replaces the need to use one hand bothhands of the operator can be available, such as one for suturing and onefor another operation. The target device (e.g., prosthetic human implantdevice, etc.) can comprise an outside surface and an inside surfacedefining an at least partially open inside cylinder cavity. The firstoperation/procedure can be a first stitch, and the first stitch can bean outside-to-inside stitch executed by puncturing a needle through theoutside surface to the inside cylinder cavity. The secondoperation/procedure can be a second stitch, and the second stitch can bean inside-to-outside stitch executed by puncturing the inside surface.For example, the first position can present the outside surface (e.g., aportion of the outside surface) to the operator and the second positioncan present the inside surface (e.g., a portion of the inside surface)to the operator.

The method(s) described herein may include steps for and/or be part of amethod for training an assistance system (e.g., an attachmentassistance, suture assistance system, etc.). The method can comprisemanipulating a position of the/an automated fixture (e.g., automatedsuture fixture) to a first desired position, storing first data thatindicates the first desired position, manipulating the position of theautomated fixture (e.g., automated suture fixture) to a second desiredposition, and storing second data that indicates the second desiredposition, wherein the second data is stored in association with thefirst data (e.g., the first data and the second data can be associatedwith each other as part of a common procedure script, for example,representing different positions for different steps of a commonprocedure). The method can further comprise generating the first data atleast in part by capturing position information indicative of the firstdesired position when the automated fixture (e.g., automated suturefixture) is in the first desired position, and generating the seconddata at least in part by capturing position information indicative ofthe second desired position when the automated fixture (e.g., automatedsuture fixture) is in the second desired position.

Manipulating the position of the automated fixture (e.g., automatedsuture fixture) can involve manually manipulating the automated suturefixture, manually manipulating an arm component of the automated suturefixture, and/or inputting positioning information using a user inputdevice. For example, user input device(s) that can be used include ajoystick device, pedal(s), button(s), electronic input(s), touchscreencontrol, other input device or mechanisms, or a combination of inputdevices and/or mechanisms. The method can further comprise, after saidmanipulating the position of the automated fixture (e.g., automatedsuture fixture) to the first desired position, providing user input totrigger said storing the first data. For example, the user input caninvolve pressing a foot pedal, button, electronic input, touchscreencontrol, etc.

The method can further comprise focusing a camera on a target device(e.g. a suture target device, prosthetic implant device, heart valve,etc.) held by the automated fixture (e.g., automated suture fixture)when the automated fixture (e.g., automated suture fixture) is in thefirst desired position, wherein the first data indicates a focus settingof the camera. The camera can be configured to remain focused on thesuture target device when the automated fixture (e.g., automated suturefixture) is in the second position without adjustment of the camera'sposition or focus. In certain embodiments, the method further comprisespositioning a camera to a first position when the automated fixture(e.g., automated suture fixture) is in the first desired position, andpositioning the camera to a second position when the automated fixture(e.g., automated suture fixture) is in the second desired position,wherein the first data indicates the first position of the camera andthe second data indicates the second position of the camera.

The method(s) can include using an assistance system (e.g., amanufacturing assistance system, an attachment assistance system, asuturing assistance system, inspection assistance system, etc.).

An assistance system (e.g., a suturing assistance system, manufacturingassistance system, attachment assistance system, etc.) can comprise anautomated fixture (e.g., automated suture fixture) comprising aplurality of motorized actuator devices and a holder (e.g., a targetholder, suture target holder, holder assembly, holder device, holdercomponent, etc.). The automated fixture (e.g., automated suture fixture)can be configured to rotate a target device (e.g., a target suturedevice, implant, heart valve, prosthetic human implant, etc.) connectedto, mounted to, or otherwise supported by the holder. The assistancesystem (e.g., suturing assistance system, etc.) can include avisualization or imaging system (e.g., a camera system, etc.) configuredto generate an enlarged image of the target device (e.g., target suturedevice, etc.) and a display, monitor, or screen (e.g., a suture targetdisplay) configured to display or show the enlarged image. The display(e.g., suture target display, monitor, screen, etc.) can indicate atarget position (e.g., a target suture position, target inspectionposition, target operation position, etc.) associated with the targetdevice (e.g., target suture device, etc.). The target device (e.g.,target suture device) can be a heart valve, implant, prosthetic humanimplant, etc., and/or a component thereof.

The assistance system (e.g., suturing assistance system, etc.) canfurther comprise a controller configured to direct the visualizationsystem (e.g., camera system) to capture image data associated with aprocedure (e.g., a suturing procedure, inspection procedure, otherprocedure, etc.) and store the image data. The image data can be storedwith metadata identifying at least one of the suturing procedure and anoperator associated with the suturing procedure, as well as otherinformation.

The automated fixture (e.g., automated suture fixture) can be configuredto adjust a tension of the automated fixture (e.g., automated suturefixture). The automated fixture (e.g., automated suture fixture) caninclude a pressure plate component configured to adjust the tension ofthe automated fixture (e.g., automated suture fixture).

The display (e.g., suture target display, monitor, screen, etc.) cancomprise a reticle. For example, the reticle can comprise a circularreticle, which can include notches for stitch counting, and/or a ruler.The display can be configured to display/show instructions (e.g.,suturing instructions, step instruction, procedure instructions, etc.)in connection with a procedure (e.g., suturing procedure, inspectionprocedure, other procedure, etc.). The assistance system (e.g., suturingassistance system) can provide for reduced physical strain on anoperator thereof compared to dual-hand or two-handed procedures (e.g.,dual-hand or two-handed suturing procedures, etc.). The holder (e.g.,target suture device holder, etc.) can be a gimbal holder assembly. Forexample, the gimbal holder assembly can comprise a three-axis gimbal.

The automated fixture (e.g., automated suture fixture) can be configuredto move the target device (e.g., target suture device, etc.) in at leastfour directions. The automated fixture (e.g., automated suture fixture)can comprise a plurality of servo motor devices daisy-chained together.The plurality of servo motor devices can be configured to be mountedhorizontally, vertically, or at another angle relative to the groundand/or other servo motor devices. The visualization/imaging system(e.g., the camera system) can comprise a first camera and a secondcamera, the first and second cameras collectively configured to provideimages of two different views of the target device (e.g., target suturedevice) or two different views showing different portions of the targetdevice. The automated fixture (e.g., automated suture fixture) cancomprise an encoder associated with an articulation arm, the encoderconfigured to provide position information for the articulation arm.

An automated fixture (e.g., automated suture fixture) can comprise aplurality of actuator devices (e.g., motorized actuator devices). Eachof the actuator devices (e.g., motorized actuator devices) can comprisea motor and a rotating support member coupled to a rotor component ofthe motor. A holder assembly or holder (e.g., a suture target holderassembly, etc.) can be attached to the rotating support member of adistal actuator device of the plurality of actuator devices (e.g.,motorized actuator devices) and can be configured to hold a targetdevice (e.g., a prosthetic heart valve device, implant device, etc.).Each of the plurality of actuator devices (e.g., motorized actuatordevices) can be fixed to one or more other actuator devices of theplurality of actuator devices (e.g., plurality of motorized actuatordevices). Furthermore, the automated fixture (e.g., automated suturefixture) can be configured to receive control signals and to rotate therotating support members of one or more of the plurality of actuatordevices (e.g., motorized actuator devices) based on the control signals.

Each of the plurality of actuator devices (e.g., motorized actuatordevices) can further comprise a servo feedback component configured togenerate a signal indicating a position of a respective rotor component.The servo feedback component can be a digital encoder. The plurality ofactuator devices (e.g., motorized actuator devices) can comprise one ormore base actuator devices and at least one intermediate-stage actuatordevice fixed at a base thereof to the rotating support members of theone or more base actuator devices, wherein the distal actuator devicecan be fixed at a base thereof to the rotating support member of theintermediate-stage actuator device. The base of the intermediate-stageactuator device can be fixed to the rotating support members of the oneor more base actuator devices via a connector plate mounted to therotating support members of the one or more base actuator devices. Therotating support members of the one or more base actuator devices can befixed to one another. The one or more base actuator devices can consistof one motorized actuator device, or two motorized actuator devices, ormore motorized actuator devices. The holder assembly or holder (e.g.,suture target holder assembly) can comprise one or more componentsconfigured to rotate about an axis substantially orthogonal to an axisof rotation of the rotating support member of the distal actuatordevice. The holder assembly or holder (e.g., suture target holderassembly) can comprise one or more components configured to rotate aboutan axis substantially parallel to an axis of rotation of the rotatingsupport member of the distal actuator device.

An assistance system (e.g., suturing assistance system, manufacturingassistance system, inspection assistance system, other procedureassistance system, etc.) can comprise an automated fixture (e.g.,automated suture fixture) comprising a plurality of actuator devices(e.g., motorized actuator devices) and a holder (e.g., a suture targetholder, etc.). The automated fixture (e.g., automated suture fixture)can be configured to position a target device (e.g., target suturedevice, implant, heart valve, etc.) mounted to the holder. Theassistance system and/or automated fixture can include a data store(e.g., memory, database, etc.) storing procedure script data (e.g.,suturing procedure script data, inspection script data, manufacturingscript data, other procedure script data, etc.). The procedure scriptdata (e.g., suturing procedure script data, etc.) can include a data setrepresenting a plurality of positions of the automated fixture (e.g.,automated suture fixture) for a procedure (e.g., for a suturingprocedure, inspection procedure, manufacturing procedure, otherprocedure, etc.). The assistance system and/or automated fixture caninclude a controller configured to access the procedure script data(e.g., suturing procedure script data, etc.) and provide positioncontrol signals to the automated fixture (e.g., automated suturefixture) based at least in part on the procedure script data (e.g.,suturing procedure script data, etc.). The target device (e.g., targetsuture device) can be a prosthetic human heart valve implant device,etc.

The controller can be further configured to select the data set fromamong a plurality of data sets of the procedure script data (e.g.,suturing procedure script data). For example, the selecting can be basedat least in part on operator profile information and/or user inputreceived by the controller. Optionally, an operator profile can beapplied to or combined with procedure script data to generateindividualized procedure script data particular to the preference and/orcharacteristics of the operator. The plurality of data sets can includea first data set corresponding to a right-handed execution of thesuturing procedure and a second data set corresponding to a left-handedexecution of the suturing procedure.

Other steps, features, components, etc. not specifically mentioned inthese examples, but described elsewhere herein or otherwise known canalso be included and/or used with the examples described here.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments are depicted in the accompanying drawings forillustrative purposes and should in no way be interpreted as limitingthe scope of the inventions. In addition, various features of differentdisclosed embodiments can be combined to form additional embodiments,which are part of this disclosure. Throughout the drawings, referencenumbers may be reused to indicate correspondence between referenceelements.

FIG. 1 illustrates an implantable prosthetic valve device according toone or more embodiments.

FIG. 2 illustrates a perspective view of a prosthetic heart valve inaccordance with one or more embodiments.

FIG. 3A illustrates a frame for a support stent for a surgical valve inaccordance with one or more embodiments.

FIG. 3B illustrates the frame of FIG. 3A covered with fabric accordingto one or more embodiments.

FIG. 4 illustrates an operator performing operations on an implantdevice in accordance with one or more embodiments.

FIG. 5 illustrates a close-up view of a heart valve implant device beingsutured using manual holding and suturing according to one or moreembodiments.

FIG. 6 illustrates a close-up view of a fabric associated with animplant device according to one or more embodiments.

FIG. 7A illustrates a block diagram illustrating a suturing system inaccordance with one or more embodiments.

FIG. 7B illustrates an operator executing suture operations with respectto an implant device using a suture assist system in accordance with oneor more embodiments.

FIGS. 8A, 8B, and 8C illustrate respective stages of an operatorexecuting a suturing operation on an implant device in accordance withone or more embodiments.

FIG. 9 illustrates a display monitor displaying and image of a targetsuture position for a prosthetic human implant suturing procedure inaccordance with one or more embodiments.

FIG. 10 illustrates a block diagram illustrating a control system forcontrolling an automated suture fixture according one or moreembodiments.

FIG. 11 illustrates a perspective view of an automated suture fixture inaccordance with one or more embodiments.

FIG. 12 illustrates a distal articulation arm of an automated suturefixture coupled to a holder component in accordance with one or moreembodiments.

FIG. 13 illustrates a holder device in accordance with one or moreembodiments.

FIG. 14 illustrates an implant device disposed about a holder componentin accordance with one or more embodiments.

FIG. 15 illustrates a gimbal-type holder assembly in accordance with oneor more embodiments.

FIG. 16 illustrates a flow diagram illustrating a process for training asuture assist system to implement a suture assist procedure according toone or more embodiments.

FIG. 17 illustrates a flow diagram illustrating a process for executinga suturing procedure in accordance with one or more embodiments.

FIGS. 18, 19, 20, 21, 22, 23, 24, and 25 illustrate views of asnake-like configuration of an automated fixture in accordance with oneor more embodiments.

FIG. 26 illustrates a perspective view of a mount or holderdevice/assembly in accordance with one or more embodiments.

FIG. 27 shows a perspective view of a holder ring that can be used tohold and rotate a target device in accordance with one or moreembodiments.

FIGS. 28 and 29 illustrate an exemplary automated suture fixture havinga configuration for an articulation arm that includes a plurality ofactuator devices that are oriented to provide additional verticalsupport.

FIG. 30 illustrates an exemplary automated suture fixture having anarticulation arm.

FIG. 31 illustrates an exemplary holder assembly that extends distallyfrom an articulation arm to allow access to an internal portion of atarget device from an in-flow or out-flow approach.

FIG. 32 illustrates a block diagram of an example of a fully automatedsuturing system.

FIG. 33 illustrates an example fully automated suturing system.

FIGS. 34A, 34B, 34C, 34D, 34E, and 34F illustrate an example suturingprocedure using a double-tipped needle and dual-coordinated suturingarms.

FIGS. 35A, 35B, 35C, 35D, 35E, 35F, 35G, and 35H illustrate an examplesuturing procedure using a standard needle and a single suturing arm.

DETAILED DESCRIPTION

The headings provided herein are for convenience only and do notnecessarily affect the scope or meaning of the claimed invention.

Although certain preferred embodiments and examples are disclosed below,inventive subject matter extends beyond the specifically disclosedembodiments to other alternative embodiments and/or uses and tomodifications and equivalents thereof. Thus, the scope of the claimsthat may arise herefrom is not limited by any of the particularembodiments described below. For example, in any method or processdisclosed herein, the acts or operations of the method or process may beperformed in any suitable sequence and are not necessarily limited toany particular disclosed sequence. Further, one or more steps disclosedwith respect to one method may be incorporated into other methodsdisclosed herein. Various operations may be described as multiplediscrete operations in turn, in a manner that may be helpful inunderstanding certain embodiments; however, the order of descriptionshould not be construed to imply that these operations are orderdependent. Additionally, the structures, systems, and/or devicesdescribed herein may be embodied as integrated components or as separatecomponents. For purposes of comparing various embodiments, certainaspects and advantages of these embodiments are described. Notnecessarily all such aspects or advantages are achieved by anyparticular embodiment. Thus, for example, various embodiments may becarried out in a manner that achieves or optimizes one advantage orgroup of advantages as taught herein without necessarily achieving otheraspects or advantages as may also be taught or suggested herein.Features described with respect to one exemplary embodiment may beincorporated into other embodiments disclosed herein even if notspecifically described with respect to the embodiment.

Overview

Prosthetic heart valve implants, as well as many other types ofprosthetic implant devices and other types of devices, can includevarious sutured components and/or portions. For example, a sealingportion, skirt, etc. can be sutured to a frame of a prosthetic heartvalve to help prevent blood from leaking around the outer edges orcircumference of the prosthetic heart valve. Execution of sutures by ahuman operator may be relatively difficult and/or cumbersome in certainconditions. For example, where small stitches are to be made with highprecision, the complexity and/or associated operator burden may resultin injury and/or undesirably low quality of products. Furthermore,certain heart valve implant devices may require upward of a thousandsutures, which can involve substantially labor-intensive anderror-susceptible suturing procedures. Therefore, collaborative suturingaids can be desirable to improve quality and/or to reduce thepossibility of operator strain.

Certain embodiments disclosed herein provide collaborative heart valvesuturing systems, devices, and/or methods for providing suturingassistance for point-by-point suturing procedures based on the physicalmanipulation and/or positioning of one or more automated mechanicalarticulating fixtures, components, and/or subassemblies. Sucharticulating fixture(s) or component(s) may be configured to hold orsecure a prosthetic human heart valve implant device or other suturingsubject or implant device having one or more components or portions thatmay advantageously be sutured together. Suture assistance systems,devices, and/or processes in accordance with the present disclosure mayimplement a focused visual display system configured to provide visualaids for stitch targeting, operator instruction communication, or thelike. The various embodiments relating to heart valve suturing presentedherein can be applicable to heart valves having any type of suturingand/or structural configuration or pattern. Examples of heart valvestructures and heart valve suturing techniques that may be applicable tocertain embodiments presented herein are disclosed in WIPO PublicationNo. WO 2015/070249, the entire contents of which is hereby expresslyincorporated by reference for all purposes.

FIG. 1 illustrates an implantable prosthetic human valve device 110according to one or more embodiments. The features of valve 110described herein can apply to other valves, including other valvesdescribed elsewhere herein. The valve 110 can be, for example, atranscatheter heart valve (THV), balloon-expandable heart valve, and/ormechanically-expandable heart valve. The valve 110 in the illustratedembodiment can generally comprise a frame, or stent, 112, a leafletstructure 193 supported by the frame 112, and a sealing member or skirt116 secured (e.g., sutured) to the outer surface of the leafletstructure 193. In certain embodiments, the valve 110 may be configuredto be implanted in the annulus of a native heart valve of a human, suchas an aortic valve. However, the valve 110 can additionally oralternatively be adapted to be implanted in other native valves of theheart, or in various other vasculature, ducts, or orifices of the body,or in grafts, docking stents, docking stations, rings, etc. implanted inthe body. The lower end 180, according to the illustrated orientation,of the valve 110 may represent an inflow end, while the upper end 182,according to the illustrated orientation, of the valve 110 may representan outflow end.

The valve 110 and the frame 112 may be configured to be radiallycollapsible to a collapsed or crimped state/configuration forintroduction into the body using a delivery catheter, and further may beconfigured to be radially expandable to an expanded state/configurationfor implanting the valve at a desired location in the body (e.g., thenative aortic valve). In certain embodiments, the frame 112 may comprisea plastic, polymer, shape memory material, or metal expandable materialthat permits crimping of the valve 110 to a smaller profile for deliveryand expansion of the valve. In one embodiment, an expansion device, suchas the balloon of a balloon catheter or a tool for mechanical expansion,may be used to expand or help expand the valve. In certain embodiments,the valve 110 may be a self-expanding valve, wherein the frame is madeof a self-expanding material such as a shape memory material or metal(e.g., Nitinol). Self-expanding valves may be able to be crimped to asmaller profile and held in the crimped state with a restraining device,such as a sheath covering the valve. When the valve is positioned at ornear the target site, the restraining device may be removed or retractedto allow the valve to self-expand to its expanded, functional size or toa deployed configuration.

The sealing portion or skirt 116 may comprise a single piece or multiplepieces or material (e.g., cloth, polymer, etc.) with opposite ends thatare secured to each other to form the annular shape shown in FIG. 1 orextend around a circumference of the valve. In certain embodiments, theupper edge of the sealing portion or skirt 116 can have an undulatingshape that generally follows the shape of struts of the frame 112. Inthis manner, the upper edge portions of the sealing portion or skirt 116can be tightly secured to respective struts with sutures 156. Thesealing portion or skirt 116 may be placed on the outside of the frame112 or on the inside of the frame 112 (as shown) and an upper edgeportion of the sealing portion or skirt 116 may be wrapped around theupper surfaces of the frame struts and secured in place with sutures.The sutures 156 may serve to provide a durable attachment of the sealingportion or skirt 116 to the frame 112.

The leaflet structure 193 can comprise three leaflets (as shown inFIG. 1) in certain embodiments, which can be arranged to collapse in atricuspid arrangement. Although a three-leaflet embodiment isillustrated, it should be understood that valve implants suturedaccording to embodiments disclosed herein may have any number ofleaflets, such as, for example, two or four. The leaflets 193 may beformed from separate flaps of material or tissue, such as, for example,xenograft tissue (e.g., bovine pericardium), or all three leaflets canbe derived from a single xenograft valve (e.g., a porcine valve). Thelower edge of leaflet structure 193 may have a variety of shapes. Incertain embodiments, the lower edge of the leaflet structure 193 mayhave an undulating, curved, and/or scalloped shape that may be suturedto the frame 112. The leaflets 193 can be secured to one another attheir adjacent sides to form commissures 184 of the leaflet structure,where the edges of the leaflets come together. The leaflet structure 193can be secured to the frame 112 using any suitable techniques and/ormechanisms. For example, the commissures 184 of the leaflet structuremay be aligned with the support posts 118 and secured thereto, e.g.,using sutures, adhesive, clamping portions, crimping, and/or otherattachment means. In one embodiment, the point of attachment of theleaflets 193 to the posts 118 can be reinforced, e.g., with barscomprising a relatively rigid material, such as stainless steel.

FIG. 2 is a perspective view of a prosthetic human heart valve 210 inaccordance with one or more embodiments. The heart valve 210 may includea peripheral sealing ring structure 291 configured to provide supportfor nesting the heart valve 210 in a heart valve cavity and/or restingupon, or attached to, an annulus or other structure of the heart. Thevalve 210 can further include a frame member 292, such as a metal frame,which may provide support for a plurality of flexible leaflets 293 andcan define three upstanding commissure posts 294, wherein the leaflets293 can be supported between the commissure posts 294. In oneembodiment, as shown in FIG. 2, the sealing ring 291 can attach aroundthe periphery of the frame member 294 at the inflow end of the valve210, with the commissure posts 294 projecting in the outflow direction.

The leaflets 293 may be formed from separate flaps of material ortissue, such as, for example, xenograft tissue (e.g., bovinepericardium), or all three leaflets can be derived from a singlexenograft valve (e.g., a porcine valve). The leaflets 293 can be securedand supported both by the commissure posts 294, as well as along arcuatecusps of the frame member between the commissure posts.

FIG. 3A shows a frame 392 for a support stent for a surgical heart valvesuch as the valve 210 of FIG. 2. The frame 392 can include multiplecusps curved toward an axial inflow end alternating with multiplecommissures 322 projecting toward an axial outflow end, the supportstent 392 defining an undulating outflow edge. The support stent 392 cancomprise a wireform 320 having three upstanding commissures 322alternating with three cusps 324 which generally circumscribe acircumference. A stiffening band 326 may be disposed within or withoutthe wireform 320. The inflow edge of the band 326 can conform or atleast partially conform to the cusps 324 of the wireform 320 and may becurved in the outflow direction in between in the region of the wireformcommissures 322, e.g., as shown in FIG. 3A. In certain embodiments, thesupport stent 392 provides the supporting structure of a one-wayprosthetic heart valve like the valve 210 of FIG. 2.

FIG. 3B illustrates the frame of FIG. 3A covered with fabric 340,wherein the fabric 340 may be sutured in one or more portions to securethe fabric 340 as a covering for the frame 392. The fabric-coveredsupport stent 342 may be generally tubular and may include multiplecusps 344 curved toward an axial inflow end alternating with multiplecommissures 346 projecting toward an axial outflow end. The supportstent 342 may comprise an undulating outflow edge about which the fabric340 is secured held. In certain embodiments, a seam 350 may be suturedadjacent an inflow edge 352 that secures the fabric 340 about thesupport stent. The seam 350 is shown slightly axially above the inflowedge 352 for clarity, although it may be located directly at the inflowedge or even inside the support stent. In one embodiment, one or moreseams may be located in other positions along the fabric. The sutures ofthe support stent 342 may be executed or added in multiple ways.Furthermore, although certain stitches are illustrated in FIG. 3B, thesupport stent 342 and/or valve implant 210 of FIG. 2 can comprise anytype or number of stitches or sutures. For example, the support stent342 and/or one or more other components of the associated implantdevice, can also have leaflets and/or other materials sutured thereto.

Suturing of prosthetic heart valve devices and/or other implant devices,such as those described above, can be performed in various ways. Forexample, certain handheld processes for suturing prosthetic humanimplant devices can be implemented in which an operator utilizes bothhands for holding, securing, and/or suturing the implant device. FIG. 4illustrates an operator 405 performing operations on a prosthetic humanimplant device 410. For example, the operator 405 may suture an outerwireframe of the device 410 to an inner skirt or cloth, as describedabove, where the implant device 410 is a transcatheter heart valvedevice. In some embodiments, the implant device 410 may be a surgicalvalve device, or other type of implant device. The implant device 410can be the same as or similar to any of the valves described herein orcan be a different type of valve or implant device.

As illustrated in the diagram of FIG. 4, in some processes, an operator405 may need to utilize both of the operator's hands for executingrelevant suturing operations. For example, a first hand 406 may be usedto hold and/or secure the implant device 410, wherein a second hand 407may be used to manually operate a suturing needle or the like.

For the operator 405 to effectively execute the relevant suturingoperations on the implant device 410, it may be necessary or desirablefor the view of the implant device 410 to be magnified or otherwiseenhanced in some manner. For example, as shown, the operator may furtherutilize a magnification system 460, such as a microscope, which maycomprise an eyepiece component 461 as well as one or more lenses and/orrefractive elements 463. In certain embodiments, the magnificationsystem 460 may be designed such that the operator 405 may have a line ofsight 409 at a first angle, wherein the magnification system 460 isconfigured to at least partially reflect light therein at a downwardangle 408 to provide a depth of field at a targeted distance from therefractive elements 463. By holding the implant device 410, or targetportion thereof, within the depth of field of the magnification system460, the operator 405 may be able to observe an enhanced view of theimplant device 410 or target portion thereof, which may be desirable ornecessary to execute the precise suturing operations for effectivelysuturing the implant device 410.

In certain configurations, the use of a microscope as a visual aid insuturing implant devices may present ergonomic issues with respect toposture and/or vision of the operator 405. For example, the workingplane presented by the microscope, with which the operator may bealigned when operating the microscope, may not adequately conform to thenatural body position of the operator. To bring the operator's eyes intonecessary proximity with the eyepiece 461 of the magnification system460, undesirable neck and/or back strain or stress may be caused as theoperator maintains the necessary posture for viewing the implant device410 through the eyepiece 461. Therefore, use of a microscope, or similarmagnification or viewing system, may be undesirable with respect toergonomic and/or vision concerns.

Alternative systems and methods for visual aid in implant suturing mayinvolve, for example, digital video systems, which may help to reducethe possibility of operator neck strain, among other possible benefits.However, such systems may present difficulty with regards to focusingthe implant or part being operated on under the camera associated withthe video system when the implant or part is manually handled by theoperator. With handheld operation, focus of the camera may be blurredand/or distorted when the implant or target part moves or is not alignedcorrectly with the lens axis, which may result in a loss of depthperception and/or other problems. For example, displays of a cameraimage can appear blurred due to slow pixel response times, refreshtimes, etc. when an implant or target part moves. This can be especiallyproblematic when displaying high resolution images/video and/ormagnifying the images/video. Furthermore, where the operator is requiredto hold the target implant, alteration of the viewing angle may furtherrequire twisting and/or contorting of the operator's hands in order toposition the target implant, which may result in sub-optimalpositioning. In addition, the location of the target implant may be suchthat a different viewing angle is required by the operator to view thetarget part than is required to view the monitor of the video system,which may cause eyestrain and/or other issues. Alternative solutions forvisual aid in implant suturing operations may involve the use of a glassvisor or the like, which may provide beneficial performance with respectto hand-eye coordination and/or neck placement. However, such tools mayprovide relatively poor zooming capabilities, and may cause eyestrainfor the operator over extended periods of time.

FIG. 5 illustrates a close-up view of a prosthetic human implant devicebeing sutured using manual holding and suturing, as described above. Asshown, for handheld suturing solutions, a first hand 506 may be requiredto hold the target implant device 510, while a second hand 507 may berequired to manipulate the suturing needle 509, or the like. Accordingto certain processes, the operator may be required to hold one or morehands in a substantially constant position over prolonged periods oftime to maintain the target implant device 510 (or desired portionthereof) within the depth of field of a microscope. Furthermore, theoperator may be required to squeeze, push, pull, or otherwise exertmanual force on one or more portions of the target implant device 510and/or suture needle 509, thereby causing strain on muscles, joints, orthe like, of the operator's hands and/or other anatomy. In certainembodiments, up to 20 pounds or more of force may be required to beexerted by the operator's hands in certain operations. Such forces maybe required repeatedly throughout a suturing process and may result invarious injuries to the operator.

Visual magnification and/or accurate positioning of an implant devicemay be necessary or desirable due at least in part to the dimensions ofthe cloth or other material being sutured in an implant suturingoperation. For example, FIG. 6 illustrates a close-up view of a fabricassociated with an implant device according to one or more embodiments.Such fabrics may comprise woven strands forming ribs having relativelysmall gaps therebetween. For example, each rib in a fabric region to besutured may have a thickness t of approximately 0.2 mm, or less. Forcertain processes, the operator may necessarily or desirably wish toposition and sew such a fabric within one-rib accuracy. Therefore,precise positioning and focusing of suturing components and targets isdesirable.

In certain implementations, suturing (e.g., implant suturing) or otherprocesses could be performed using one or more holder devices, such as ahandheld gooseneck holder or mounted holder type device. However, suchdevices may not be rapidly adjustable to new locations, which maynegatively impact performance efficiency or speed. Furthermore,refocusing of a microscope or other vision system to a locationassociated with such a holder device may be difficult. Handheld holdersand tools may require operators to hold the holder or tool with onehand, thereby limiting the ability of the operator to use such holdinghand to adjust the fabric or other material for tensioning and/orrealignment.

Certain embodiments disclosed herein provide systems and processes forsuturing components and/or devices (e.g., prosthetic human implantdevices) using multi-access assist systems, such as in adirect-human-assist mode for suturing implant devices. Such systems canbe configured to articulate a component/device (e.g., an implant devicesuch as a human prosthetic heart valve device, etc.) preciselyunderneath an imaging system or visualization system (e.g., ahigh-definition (HD) camera, multiple cameras, etc.), wherein theprecise positioning of the component or device can allow for necessaryor desirable focusing and imaging of a desired position or targetposition (e.g., a current suture position or other position to beprocessed, inspected, etc.). Furthermore, the system can be furtherconfigured to reposition the component and/or imaging system toanticipate a subsequent position (e.g., a subsequent suture position,review or inspection position (e.g., for quality control inspection), orother position). In certain embodiments, a display associated with thesystem or implant suturing system can include visual aids to assist theoperator in locating and/or interpreting an operation (e.g., a sutureoperation, review or inspection operation, processing operation,training operation, or other operation) to be performed. For example,such a display monitor may provide crosshairs, visual aids, overlays,comparative images, patterns, maps, and/or a type of reticle, or thelike, to indicate the desired position or result (e.g., the desiredsuture position or completed suture).

Embodiments disclosed herein may provide improved ergonomics foroperators, which may reduce medical costs and/or liabilities associatedwith hand, neck, shoulder, and/or vision injuries, for example.Furthermore, embodiments disclosed herein may provide improvedreliability and/or repeatability for suturing processes, review orinspection, or other processes. For example, suturing an implant deviceor heart valve can require suture accuracy within a millimeter, half amillimeter, or less, but a suture location may be easily missed betweenribs or threads, especially when implementing dual-handheld suturingprocedures. Embodiments of the present disclosure can facilitateimproved precision and can also provide the freedom of only requiring asingle hand for certain suturing operations and/or other operations(e.g., inspection, processing, etc.).

Positional accuracy may be improved with respect to embodiments of thepresent disclosure through the use of systems incorporating one or morecameras, articulation arms, automated fixtures, monitors, etc., and/or acombination of more than one of these. Such systems can be used toposition a target component or device (e.g., an implant device such as ahuman prosthetic heart valve device, etc.) in a desirable position witha relatively high degree of accuracy and repeatability. Such systems canalso facilitate identifying desired positions (e.g., suture positions,inspection positions, etc.), such as with respect to frame and skirtsuturing for a transcatheter heart valve.

Embodiments disclosed herein and the incorporation of features accordingto the present disclosure can provide or be used for training and/ortechnology transfer that may ultimately result in substantially reducedprocess or operation times and can help reduce the difficulty ofoperations and procedures. For example, it can be relatively difficultto convey training to an operator with respect to a particularprocedure, and improved solutions disclosed herein can help reduce thecomplexity of certain procedures with enhanced training and/or bydiverting certain procedures to mechanical components configured tomanipulate the target device or component as necessary. Training ofoperators may be completed with improved efficiency, thereby potentiallyreducing costs and time. Embodiments can be used to guide operatorsthrough desired procedures or operations and demonstrate correctpositioning and results. Quality-control feedback can also be providedto further improve quality for manufacturing and training. For example,heart valve implant suturing processes can be relatively labor-intensiveand involve relatively long process times, which can result in increasedcosts and/or injuries. Embodiments disclosed herein and incorporation offeatures according to the present disclosure may provide for operatortraining and/or technology transfer that may ultimately result insubstantially reduced process times, as well as reducing the difficultyof certain operations of implant suturing procedures. According tocertain implementations, it can be relatively difficult to conveytraining to an operator with respect to suture locations for aparticular procedure, especially where such procedures are implementedusing dual-hand body mechanics to hold and manipulate the target device.Improved solutions disclosed herein can reduce the complexity of certainoperations by diverting certain operations to mechanical components(e.g., automated fixtures) configured to manipulate the target device asnecessary. Training of operators is simplified and may be completed withimproved efficiency, thereby potentially reducing costs and time.Correct positioning and images of correct suturing can also bedemonstrated and displayed to aid training. Quality-controlled feedbackfor further improving quality for manufacturing and training purposescan be implemented, e.g., the system may be able or programmed to moveto key locations for inspection and/or recognition software may be ableto detect issues, e.g., to detect whether a suture looks correct orincorrect. This can operate similar to facial recognition software withmodifications to determine if the device or component appears to becorrectly made or configured (e.g., has the correct shape of suture, orother features, etc.). Similar recognition software can be used forother processes as well to detect whether the target device looks likeit should after a particular step, process, operation, etc. Varioussystems and/or devices disclosed herein may allow for fully automatedprocesses or partially automated processes (e.g., at least partiallyautomated implant suturing).

Operation Assist Articulation System

Embodiments disclosed herein provide for systems, devices, methods, etc.for executing one or more procedures or operations (e.g., suturingoperations, attachment operations, review or inspection operations,and/or other operations) for prosthetic heart valve implant devices forhumans and/or other types of devices or components. FIG. 7A illustratesa suturing system 700A according to one or more embodiments. One or morecomponents of the system 700A may be utilized for suturing heart valvedevices or other implant devices, as described herein. In oneembodiment, the system 700A includes a controller 730A configured todirect one or more components of an automated fixture assembly 770A(often referred to as an automated suture fixture assembly herein butcan be an automated fixture or articulation device used for otheroperations or procedures beyond suturing/sewing as well) according to aparticular process (e.g., a suture-assist process). The controller 730Acan comprise one or more hardware and/or software components designed togenerate and/or provide fixture control signals (e.g., suture fixturecontrol signals) and/or data associated with one or more steps of asuturing process or other process. For example, the controller 730A cancomprise a computing device including one or more processors 732, aswell as one or more data storage devices or components 734, which caninclude volatile and/or nonvolatile data storage media. Althoughillustrated as a separate component in the diagram of FIG. 7A, thecontroller 730A can be a component of the automated suture fixtureassembly 770A. In some embodiments, the data storage 734 is configuredto store process script data (e.g., suture process script data), whichcan comprise data indicating positioning of one or more components ofthe system 700A for various steps and/or stages of the suturing processor other process (e.g., for inspection, procedures, etc.). A processcomprising a plurality of steps can be represented at least in part bynumeric or other data sets representing positioning information for oneor more components of the automated fixture assembly and/or one or moreadditional components of the system 700A for each respective step orstage of the process. For example, a suturing process comprising aplurality of suturing steps can be represented at least in part bynumeric or other data sets representing positioning information for oneor more components of the automated suture fixture assembly 770A and/orone or more additional components of the system 700A for each respectivestep or stage of the suturing process.

The automated fixture assembly 770A can comprise one or more componentsconfigured to articulate, operate, and/or position one or more motorizedactuators 773A to present a target 710A (e.g., a heart valve or suturetarget), in a desirable or suitable position/presentation for convenientengagement or interaction therewith by an operator executing at leastpart of a process (e.g., a suturing process). In certain embodiments,the automated fixture assembly 770A includes a plurality of motorizedactuators 773A that are mounted, attached, or connected to one anotherin a desirable configuration to provide a desirable range of motion forthe automated fixture (e.g., automated suture fixture) for the purposeof articulating a target 710A (e.g., a suture target) associated with orheld by the automated fixture 770A. In certain embodiments, a targetholder component/assembly 771A can be associated with, or connected to,one or more of the motorized actuators 773A. The motorized actuators773A can each comprise one or more rotating, translating, or otherwisearticulating members driven by a motor, a piston, or the like. Examplesof automated suture fixture assemblies and associated components aredescribed in greater detail herein with reference to FIGS. 10, 11,18-25, 28-30, and 33-35.

The motorized actuators 773A can be configured to provide a number ofdegrees of freedom of movement for the target holder 771A and,consequently, a suture target 710A coupled to the target holder 771A. Insome embodiments, the number of degrees of freedom is greater than orequal to 3, greater than or equal to 4, greater than or equal to 5, orgreater than or equal to 6. The degrees of freedom can includepositioning in any of the three spatial dimensions (e.g., movement inthe x-axis, y-axis, and z-axis; horizontal movement, vertical movement,or a combination of horizontal and vertical movement), rotation (e.g.,rotation about the x-axis, about the y-axis, and/or about the z-axis),and/or rotation of the target holder 771A around a longitudinal axis ofthe suture target 710A (e.g., keeping the position and pointingdirection of the suture target 710A fixed while rotating the suturetarget 710A around its longitudinal axis to expose a different portionof the suture target 710A to an operator and/or camera system 760A).

In certain embodiments, the controller 730A can provide control signalsfor directing the positioning of the motorized actuators 773A based on apositioning script, suture process script, and/or user input provided byan operator. For example, the system 700A can include a user inputdevice 715A, which can be used by an operator to provide input directingthe operation of the controller 730A and/or automated fixture assembly770A. For example, user input device 715A can comprise any suitable userinput interface, such as a mechanism for user input in connection with agraphic user interface associated with an electronic display, wherein anoperator can provide input through interaction with the interface. Insome embodiments, the user input device 715A can comprise one or morephysical switches, buttons, pedals, sensors, or the like, wherein a usermay provide input through engagement of such mechanism(s). In someembodiments, the input can be provided using voice commands and/or voicerecognition software. In some embodiments, the user input device 715Acomprises a foot pedal that can be pressed or otherwise engaged by theoperator substantially at the same time as the operator is interactingwith one or more other components of the suturing system 700A. Forexample, the operator can activate the foot pedal while sitting orstanding at a suturing station and engaging with the suture target 710Awith one or more hands of the operator. For example, the operator canengage the foot pedal as a signal to advance from one step or stage ofthe present suturing operation to a subsequent step or stage, e.g., theinput device 715A can provide input to the controller to advance thesystem through a script moving the automated fixture and target to eachposition in sequence.

In some embodiments, the system 700A includes a visualization system orcamera system 760A, which can be configured to perform various imagingfunctionality for assisting with the suturing procedure being executedby the operator. The visualization systems or camera systems herein caninclude one or multiple imaging devices or cameras, e.g., multipleimaging devices or cameras might be used to add dimensions or depth tothe images. The visualization/camera system 760A can be configured togenerate an image, such as a close-up image and/or high definitionimage, of the suture target 710A (e.g., an image of a portion of thetarget 710A to be sutured, inspected, treated, etc.) and/or associatedcomponents of the automated suture fixture assembly 770A for the purposeof providing a visual aid for the operator in executing suturingoperations, inspections, or other operations. The camera system 760A cancapture image data for quality control or other purposes at variousstages of the suturing procedure or other operation. The camera system760A can operate in connection with a display system 750A, such as anelectronic computer display, or the like. Therefore, in certainembodiments, the operator can view enlarged imaging of a suture target(e.g., an image of a portion of the target to be sutured) whileexecuting suturing operations thereon, or otherwise inspecting orengaging therewith. In certain embodiments, the camera system 760Amaintains a constant focus or depth of field during multiple steps of asuturing process, while the automated suture fixture 770A articulatesthe suture target 710A in such a way as to bring a target portion of thesuture target 710A into the depth of field of the camera 760Asubstantially automatically and hold it in place during each step of theprocess so that the suture target 710A remains in focus.

FIG. 7B illustrates an operator 705 executing suture operations withrespect to a prosthetic human implant device (e.g., heart valve) 710Busing a suture assist system 700B in accordance with one or moreembodiments. Although a plurality of components and devices areillustrated in the system 700B of FIG. 7B, it should be understood thatsuture assist functionality may be implemented in systems having one ormore additional components and/or systems that omit one or morecomponents illustrated in FIG. 7B. In certain embodiments, the system700B includes an automated suture fixture 770B, which may comprise oneor more actuator devices (e.g., servo actuator devices), which may becoupled in one of various configurations allowing for an articulationarm 778B to be articulated to provide multiple degrees of freedom whenmanipulating and positioning the coupled implant device 710B. Forexample, the automated suture fixture 770B can be configured toarticulate the arm 778B towards and/or away from the operator 705, upand/or down, in a clockwise and/or counterclockwise direction relativeto one or more different axes of rotation (e.g., to move or flip theinflow end and outflow end so one or the other is closer to theoperator), in various directions/positions relative to x-, y-, andz-axes, and/or in other directions/movements. Furthermore, the arm 778Bof the suture fixture 770B and/or an associated implant holder component771B can be configured to rotate (e.g., rotate about a central orlongitudinal axis of the holder 771A, 771B and/or of the target 710A,710B) clockwise or counterclockwise in order to present differentportions or regions of the implant device 710B to the user 705. A distalarm portion 778B of the automated suture fixture 770B can allow for theoperator 705 to move the target or implant device 710B in a position toexpose one or more portions of the implant device 710B (1) to a viewingassembly 760B (e.g., a camera or microscope assembly), or lens thereofand/or (2) to the operator 705 (e.g., to the operator's hand and/or eye)to perform a procedure (e.g., a suturing step, inspection step, etc.).

In certain embodiments, the automated fixture 770B comprises a pluralityof motorized actuators (e.g., servo actuators) physically coupled to oneanother. By constructing the automated suture fixture 770B using aplurality of motor components (e.g., servo motor components), the system700B may be relatively inexpensive and/or advantageously provide anenhanced range of motion, as well as multiple axes of rotation. Incertain embodiments, the automated suture fixture 770B comprises aplurality of actuator devices (e.g., servo actuator devices)daisy-chained together and implemented using a software script toprovide cooperative functionality for the purpose positioning theimplant device 710B. For example, the actuator devices or servo actuatordevices (e.g., servo motor devices) can be mounted, or configured to bemounted, horizontally or vertically or at an angle, and may bearticulated in any desirable direction. For example, the automatedsuture fixture 770B can be configured to articulate in a snake-likeand/or crane-like configuration. FIGS. 18-25 and 28-30 illustrateexamples of snake-like configurations of an automated fixture that canbe used in suturing procedures as an automated suture fixture and/or inother procedures.

The configuration of the automated suture fixture 770B can provide theweight and/or size for the automated suture fixture 770B that isrelatively small and convenient for use in applications designed toassist in the positioning and manipulation of relatively small devices,such as the prosthetic human implant device 710B. The relatively smallsize of the system and automated fixture also allows for use in a morecompact workspace like those often used for suturing prosthetic heartvalve implants, e.g., the small size can fit and be used even on arelatively small desk/table, which allows for more efficient use ofbuilding and work areas. In certain embodiments, the individual actuatordevices (e.g., the individual servo actuator devices) of the automatedsuture fixture 770B can comprise brushless potentiostat and/or magneticencoder devices. In certain embodiments the actuator devices can beimplemented using piezoelectric control with analog voltage signals. Incertain embodiments, one or more components of the automated suturefixture 770B can be controlled using pulse width modulation controlsignals, such as control signals spaced by between 0 to 2 μs, forexample. In certain embodiments, multiple motor components (e.g.,multiple servo motor components) of the automated suture fixture 770Bcan share one or more common leads with a multiplex signal, such as athree-lead connection. In some embodiments, the automated suture fixture770B comprises four or five or more servo motor devices. Devices andfixtures disclosed herein can be remote-controllable or at leastpartially remote-controllable.

The automated fixture 770B (e.g., automated suture fixture) can furthercomprise a target holder assembly 771B (e.g., a suture target holderassembly), which can be configured to hold or secure the target 710B(e.g., suture target, prosthetic human implant device, etc.) that is thesubject of the process that the operator is engaged in. In certainembodiments, the suture assist system 700B comprises a camera subsystem760B. In certain embodiments, the camera 761B remains in a substantiallystatic configuration during execution of a suturing procedure, whereinthe automated suture fixture 770B articulates the target implant deviceinto desirable focus with the camera 761B during the procedure. Incertain embodiments, the camera system 760B can be configured tomanually or automatically articulate and/or focus to a target positionto provide a precise image of a target suture position for theoperator's benefit. For example, the positioning/configuration of thecamera 760B can be controlled at least in part by a controller executinga suture process script as described herein. In certain embodiments, thesystem 700B includes multiple cameras configured to providemultiple-perspective imaging (e.g., a dual-perspective imaging) of theimplant device 710B and/or automated suture fixture 770B, which can helpto eliminate or reduced blind spots and/or improve ease of operation.The suture assist system 700 can further comprise a display monitor 750B(or multiple display monitors), which can work in concert with thecamera assembly 760B and/or automated suture fixture 770B to present tothe operator 705 an image identifying a target position (e.g., a targetsuture position) to further improve precision and ease-of-use of thesystem 700B.

The assist system 700B can represent a multi-access assist system foruse in a direct human assist for procedures (e.g., for suturingprosthetic human implants, such as heart valves, for inspection andquality control, and/or for other procedures). In certain embodiments,the automated suture fixture 770B can hold the target device or implantdevice 710B and articulate the target device or implant device 710B to adesired position underneath the camera lens 761B, which can be, forexample, a high-definition (HD) camera, which can provide furtherprecision in monitoring the procedure (e.g., in the suturing procedure,inspection, or other procedure). The automated suture fixture 770B canadvantageously position the implant device 710B or target device to adesired in-focus position within the depth of field of the camera 761B,e.g., with respect to a point or region on the implant device 710B thatis to be sutured according to the suturing process.

Configuring the holder assembly 771B of the automated suture fixture770B to hold, secure, articulate, or move the prosthetic human implantdevice 710B can allow for execution of suturing operations by theoperator 705 using one less hand than may be required in systems inwhich an operator is required to manually hold the implant device in thedesired suturing position. The free hand of the operator 705 may beavailable to perform various operations not available in procedures inwhich both hands of the operator are required for handling and suturingthe implant device. For example, a free hand of the operator 705 may beused to adjust cloth being sutured, reposition suturing threads, assistwith tying knots, push or pull the needle, and/or the like. Further,allowing the free hand to rest may beneficially reduce the possibilityof pain for an operator.

The automated suture fixture 770B can be configured to align the targetor implant device 710B with the focal position of the camera system 760Bwithout the need for the operator 705 to determine and execute theappropriate positioning to provide a view of the target or a portion ofthe target (e.g., a desired suture point) on the display device 750B. Insome embodiments, the camera system 760B may further be configured toalign the camera 761B with the plane of operation presented by theautomated suture fixture 770B.

In certain embodiments, the gear train slop present in the automatedsuture fixture 770B can advantageously be less than ½ mm at a distalportion thereof. The automated suture fixture 770B can comprise one ormore encoders for articulating the various components of the device. Theposition of the one or more encoders can be designed in order to providesatisfactory precision of position of the distal end of the actuator arm778B to allow for precise positioning of the target device 710B forimaging thereof. In certain embodiments, one or more encoders can beconnected at an output portion of the automated suture fixture 770B,such that slop in the system can be corrected to position the implantdevice 710B at the precise position as directed by the script by whichthe automated suture fixture 770B is operated. In certain embodiments,one or more magnetic encoders having, for example, 12-bit resolution orother resolutions, can be utilized in connection with the automatedsuture fixture 770B.

In certain embodiments, a distal articulation arm 778B of the automatedsuture fixture 770B can generally present a downward-angled position toallow for proper positioning of the implant device 710B with respect tothe position of the operator 705, as shown in FIG. 7B. Furthermore, thecamera 761B can advantageously provide an at least partial side angle ofthe implant device 710B, which can provide a good working view of thetarget suture position with respect to the operator 705 orientationshown. With the automated suture fixture 770B configured to position theimplant device 710B substantially within the depth of field of thecamera 761B, it may not be necessary for the camera 761B to adjust focusfrom one step of the suturing procedure or other procedure to the next.

The suture assist system 700B can be configured such that thearticulation arm 778B of the automated suture fixture 770B can bemanually or electronically altered by the operator 705 to train theautomated fixture 770B to a custom position, e.g., to record/programposition information so the system or automated fixture 770B can returnto that position automatically during a procedure. For example, theoperator 705 may manipulate the articulation arm 778B to provideaccessibility to as much of the target or valve 710B as possiblevis-à-vis the desired work position or posture of the operator 705. Thearticulation arm 778B may be mechanically moved into the desiredposition and frozen or held in that position, wherein in the frozen/heldposition, a data capture is executed representing the position of thearm 778B, such that the position can be re-created at a future time inconnection with a similar operation/procedure. The position information(e.g., information representative of a position or that can be used tocause the automated fixture and/or articulation arm to move to aparticular position) can be saved as part of a procedure script (e.g., asuturing procedure script, inspection script, etc.). For example, sincea procedure for suturing and/or a procedure for inspecting the implantdevice 710B can, and generally will, involve multiple differentpositions of the implant device 710B, the system 700B can be configuredto store a data script comprising information relating to each stepand/or position of the procedure, such that the specific positions/stepsmay be replayed at a later time connection with the procedure (e.g., animplant suturing and/or inspection procedure associated with the implantdevice 710B).

In certain embodiments, utilization of an automated suture fixture likethat shown in FIG. 7B and described above may allow for improved qualityand/or convenience associated with whip-type stitches of certain implantdevices. FIG. 8A illustrates an operator 805 executing a suturingoperation on a prosthetic transcatheter heart valve implant device 810comprising a wireframe 812 disposed about a skirt component 816. Theoperation executed by the operator 805 can involve a whip-type stitch,wherein a needle 809 and thread 817 are passed from outside of theimplant device cylinder, through the implant device cylinder, and drawnout from within the implant device cylinder. FIG. 8A shows the processstep of puncturing the outside of the implant device cylinder with theneedle 809, wherein an articulation arm 878 of the automated suturefixture 870 that holds the implant device 810 is in a slightlydownward-angled position to thereby present the exterior surface of theimplant device to the operator with the target suture position 851focused thereon. At each stage and/or step of the suturing processrepresented in FIGS. 8A-8C, the display 850 may show an image (e.g., aclose-up image and/or high-definition image) of the relevant targetposition for the respective stage/step.

FIG. 8B illustrates the operator 805 drawing out the needle 809 and/orthread 817 from the inside 819 of the cylinder of the implant device 810after the needle 809 has punctured the implant device 810 from theoutside of the cylinder portion of the implant device 810, which isshown in FIG. 8A. When the operator 805 draws the needle 809 out of theinner cylinder 819, the articulation arm 878 can articulate to present(or make more accessible) the inside (e.g., a desired portion of theinside) of the implant device cylinder to the operator to allow theoperator to more easily locate and grasp the needle 809 and/or draw theneedle 809 and thread 817 out, which can reduce the risk of catching orsnagging. In some embodiments, the implant device 810 can be maintainedin the same position or at the generally downward projecting angleassociated with the puncture operation of FIG. 8A when drawing theneedle 809 and thread 817 from inside of the cylinder of the implantdevice 810. The display monitor 850 can remain focused on the sutureposition associated with the puncture of FIG. 8A to show the threadedsuture formed by puncturing the outer cylinder of the implant device 810as shown in FIG. 8A or can focus on another portion of the target orimplant device 810 (e.g., on the location where the needle 809 will bepulled out). Presentation of the inside of the implant device cylinder819 to the operator 805 can be accomplished at least in part through therotation of the implant device 810 about a central or longitudinal axis893 thereof. For example, the holder component 880 coupled to thearticulation arm may be configured to rotate about the axis 893.

FIG. 8C illustrates the articulation arm 878 positioned in a generallyupward-projecting position in order to present to the operator 805 aportion of the inside 819 of the cylinder of the implant device 810. Bypresenting the inner surface of the cylinder of the implant device 810to the operator and to the camera lens 861, the articulation arm 878 canallow for the operator 805 to more conveniently access the target sutureposition for pulling the needle 809 through and/or using the needle 809to puncture the inside surface of the cylinder of the implant device 810(e.g., an inside surface of the transcatheter heart valve skirtcomponent, as described in greater detail above). Presenting the innersurface of the cylinder of the target device or implant device 810 canalso allow the camera lens 861 to be focused on the target sutureposition 851 and allow better display and viewing of the target sutureposition. With the target suture position 851 prominently displayed onthe display monitor 850, the operator 805 can be instructed and/orassisted in an inside-to-outside suturing step for completing the suturewrapping around the frame 821 of the implant device 810. By providingconvenient repositioning of the articulation arm 878 for exterior andinterior needle puncturing operations, the system 800 may provide ameans for suturing a transcatheter heart valve or other type of implantor target device requiring exterior-to-interior stitches and vice versa.The precise repositioning of the articulation arm 878 (e.g., accordingto a particular script or program) can reduce the risk of threadwrapping or other mis-stitching by the operator 805.

Point Imaging

FIG. 9 illustrates a display, screen, or monitor 950 for displaying animage of a target position or target suture position 951 of a targetdevice or prosthetic human implant device, e.g., the image of a targetsuture position can be displayed for a suturing procedure in accordancewith one or more embodiments. For example, the display monitor 950 canbe the same as or similar in certain respects to the display monitors750A, 750B described herein with reference to FIGS. 7A and 7B and/ordisplay monitor 850 described herein with reference to FIGS. 8A-8C. Incertain embodiments, the display 950 can be configured to display animage captured by a camera system associated therewith (not shown), suchas may be similar to certain camera systems illustrated in other figuresand described in detail herein (e.g., camera system 760A, 760B). Thedisplay 950 can provide visual targeting of a target location/targetstitch location 951 or general area using one or more on-screen visualaids. For example, the display 950 may have disposed or projectedthereon one or more crosshair guidelines 952, 953, and/or other reticletool, such as a circular reticle 955, which may encompass the targetsuture point 951. With respect to embodiments comprising crosshairguides (e.g., vertical and horizontal crosshair guides), theintersection of such crosshairs may be at a target point, which can bedesignated as the target suture point 951. Although a circle reticle isillustrated, it should be understood that reticles and/or other visualaids associated with the display monitor 950 may comprise any suitableor desirable shape configuration, or the like. Optionally, a targetlocation or point may be positioned at a particular location on thedisplay 950 (e.g., the target location or point may always or sometimesbe positioned at the center of the monitor or display) regardless ofwhether other visual aids are or are not used. Furthermore, in certainembodiments, animation overlays may be superimposed on a camera imagedisplayed on the display 950 to further assist the operator ininterpreting or identifying the target suture point and/or theassociated suturing action or other procedure the operator is to take.

With the aid of the display 950 (e.g., monitor, screen, or otherdisplay), it may not be necessary for the operator to be burdened withmanually focusing the implant device being sutured to specific focuspoints. For example, manual focus may be unnecessary when the display950 is part of a suture assist system comprising target implantarticulation mechanics and/or a camera system configured to collectivelyachieve the desired focus at the target suture point or other targetpoint for a given step of a suturing procedure or other procedure. Asanother example, an articulation arm securing or holding the targetimplant device may be configured to position the suture point of theimplant device within the depth of field or focal length of theassociated camera system. With the focused image presented clearly onthe display 950, the operator may be spared at least in part eye strainor other potential discomfort which may be associated with efforts tovisually inspect and/or configure an implant device to achieve thedesired focus. Further, proper positioning may make various steps andprocedures easier to accomplish and easier on the hands and arms of anoperator.

In certain embodiments, the visual aid(s) (e.g., crosshair 952, 953and/or circular reticles 955) can be displayed as stitch-counting visualaids. The reticle 955 can be calibrated to a desired position.Furthermore, while the crosshair target 951 can identify the targetstitch location, the circular reticle 955 can comprise additionalnotches or indicators providing further information with respect to acurrent stitch operation, such as a numbered stitch count. For example,the circular reticle 955 can rotate with each stitch as a means ofidentifying stitch count in certain embodiments. The reticle(s) can beused to index certain stitches accurately on the display 950. With thecircular reticle 955, it may not be required for the operator to countstitches, and therefore the mental burden on the operator may be atleast partially reduced and human error in the counting can beeliminated or reduced. Furthermore, with the operator able to maintainfocus on stitch without relying on himself or herself to hold theposition of the implant device in the desired orientation with respectto the magnification or visualization system, the operator can expendenergy towards other aspects of the process, thereby potentiallyimproving quality and/or efficiency. Markings associated with variousvisual aids (e.g., markings of the visual assistance reticle(s)) may beuseful in alignment, placement, and/or measurement of stitches and/orother suturing operations. In certain embodiments, the field-of-view ofthe display monitor 950 can be adjustable to conform to the preferencesof the operator, to be placed in an ergonomically beneficial position,or as appropriate for a particular suturing operation or otheroperation.

In certain embodiments, the display 950 can be configured to presentthereon operator instructions for executing suturing operations or otheroperations, as well as other information which may be pertinent to theprocedure or otherwise associated with the procedure (e.g., step by stepinstructions, reference images of correctly completed suture steps orprocedure steps, warnings/cautions, tips/suggestions, FAQs, etc.). Forexample, the display 950 can present timing elements, which can be usedto improve efficiency and/or aid the operator in determining points orperiods of time during which certain operations are to be executed. Insome embodiments in which the target implant device may comprisematerials that are required to maintain a certain degree of moisture inorder to retain desired functional properties or qualities (e.g., tissueused to form leaflets of a valve can be required to maintain a certaindegree of moisture), reminders and/or instructions may be presented onthe display 950 to the to the operator to remind the operator tosaturate or moisten such components. Furthermore, in certainembodiments, the display 950 can present qualitative measurement oranalysis information with respect to the procedure being executed by theoperator, such as sensed characteristics of the implant device and/orone or more components or features thereof, such as moisture levels,tension readings with respect to certain stitches, or the like. Thesystem can include sensors configured to detect these characteristics,e.g., moisture level sensors, tension sensors, etc. The system caninclude a timer, clock, or other time tracking device/operation to trackhow long the various steps, operations, procedures, etc. take and/or toallow an operator or other person (e.g., a supervisor) to reviewdifferent times or images associated with different times.

In certain embodiments, still images can be captured as displayed on thedisplay 950 and/or captured by the associated camera system (not shown).Such captured images can be used to provide quality-control data points.For example, image file data can be compiled and stored in associationwith the specific implant device of the procedure, the procedure, and/orthe operator involved in the procedure, wherein such information can beused to evaluate the quality and/or other aspects of the implant device,procedure, and/or operator. The display 950 can be positionable forviewing by the operator in any desirable position, which may allow forrelatively low-stress posture and/or interaction of the operator toimprove ergonomics.

Automated Suture Fixture

As illustrated in FIG. 7A and described in detail herein, suture assistsystems in accordance with the present disclosure can comprise anautomated suture fixture for articulating a suture target (e.g.,prosthetic human heart valve implant) to a desired suture position orother process position. FIG. 10 illustrates a block diagram illustratingan exemplary control system 1000 for controlling an automated suturefixture 1070 (although shown as an automated suture fixture, it can bean automated fixture used for other operations or procedures instead ofor in addition to suturing) according to one or more embodiments. Thesystem 1000 includes an automated suture fixture 1070 configured toreceive control signals from a controller module 1030. The controllermodule 1030 can comprise a combination of software and/or hardwarecomponents configured to generate control signals for at least partiallydirecting the operation of the automated suture fixture 1070 and/or oneor more components thereof.

In certain embodiments, the controller 1030 includes one or moreprocessors and/or controller circuitry configured to access suturingscript information 1034 or other script/program information maintainedby the controller in data storage thereof, or otherwise accessed by thecontroller 1030. The controller 1034 can include positioning controlcircuitry 1032 designed to interpret suturing script information orother script/program information and generate control signals forcontrolling the automated suture fixture 1070 based at least in partthereon.

The suturing script information 1034 or other script/program informationcan comprise sequential positioning information for one or morecomponents of the automated suture fixture 1070 with respect to one ormore suturing processes or other processes that the controller 1030 isdesigned to implement. For example, in some embodiments, the positioningcontrol circuitry 1032 can be configured to provide position informationfor each step of a suturing process in a sequential manner. Theadvancement from one position step to another can be directed by thecontroller 1030 based on a timer, user input, or other mechanism. Forexample, user input may be received by the controller 1030 from a userinput device 1015, such as a foot pedal or other input devicecommunicatively coupled to the controller 1030. In certain embodiments,input can be provided using (e.g., pressing or clicking) an icon orelectronic button on a display that can be clicked on or toggled toprovide input to the controller to advance the procedure and/or move theautomated fixture (e.g., to the next position). In certain embodiments,input can be provided using voice commands and/or voice recognitionsoftware to provide input to the controller to advance the procedureand/or move the automated fixture 1070 (e.g., to the next position).

The automated suture fixture 1070 can include a plurality of motorizedactuators 1071, which can be communicatively coupled to the controller1030. In certain embodiments, the motorized actuators 1071 can becoupled to one another in a daisy-chain configuration, wherein two ormore of the motorized actuators 1071 are coupled or wired together insequence.

Each of the motorized actuators 1071 can include a motor, such as a DC,AC, or brushless DC motor. The motor can be a servo motor. In certainembodiments, the motor 1072 is controlled using pulse-coded modulation(PCM), as directed by the motor control circuitry 1076. For example, themotor control circuitry 1076 can apply a pulse application for a certainperiod of time, wherein the angular positioning of a rotor component1073 is determined at least in part by the length of the pulses. Theamount of power applied to the motor 1072 may be proportional to therotational distance of the rotor 1073.

In certain embodiments, the motorized actuators 1071 can be servoactuator devices including one or more servo feedback component(s) 1074,such as a position sensor (e.g., a digital encoder, magnetic encoder,laser(s), etc.). Use of servo feedback component(s) 1074 can bedesirable in order to achieve a desirable level of confidence that themotorized actuators 1071 are positioned as directed by the controller1030 with an acceptable degree of accuracy. The servo feedbackcomponent(s) 1074 can provide an analog signal to the motor controlcircuitry 1076 indicating a position and/or speed of the rotor 1073,which can advantageously allow for relatively precise control ofposition for faster achievement of a stable and accurate rotor position.Relatively accurate positioning of an implant device may be necessary ordesirable due at least in part to the dimensions of the cloth of a heartvalve or other implant device that is sutured in an implant suturingoperation using the automated suture fixture 1070. For example, thefabric being sutured may comprise woven strands forming ribs havingrelatively small gaps therebetween. In certain embodiments, theautomated suture fixture 1070 may be required to articulate a suturetarget prosthetic human implant device within 0.2 mm accuracy, or less.Although servo motor devices and components are described herein in thecontext of certain embodiments, in certain embodiments, one or moremotorized actuators 1071 comprise stepper motors, or other types ofmotor subsystems.

The motorized actuators 1071 can further comprise motor controlcircuitry 1076, which can drive the motor 1072 according to the controlsignals received from the controller 1030. In certain embodiments, themotor 1072, in combination with the servo feedback mechanism 1074 and/ormotor control circuitry 1076, can advantageously be configured to retainthe rotor 1073 and/or attached support member in a set position fordesired periods of time. The motor 1072 can provide relatively smoothcommutation and/or accurate positioning of the associated rotor 1073.The motor 1072 can be relatively powerful relative to its size and maydraw power proportional to the mechanical load present on the rotor 1073and/or associated support member.

In certain embodiments, the servo feedback component 1074 comprises apotentiometer that is connected to the rotor 1073, which can beconsidered the output device of the motorized actuator 1071. The rotor1073 can link to the potentiometer and control circuitry 1076, whereinthe potentiometer, coupled with signals from the control circuitry,controls the angle of the rotor 1073 (and associated support member)across a rotational range, such as between 0°-180°, or further. Incertain embodiments, the rotational range of the rotor 1073 can berestricted by one or more mechanical stops, which may be built intoassociated gear mechanism(s). The potentiometer (or other servomechanism, such as an internal rotary encoder) can allow the controlcircuitry 1076 to monitor the current angle of the motor 1072 and/orrotor 1073. When the rotor 1073 is at the correct or targeted angle orposition, the motor 1072 can idle or lock in place until the nextpositioning signal is received from the controller 1030.

The automated suture fixture 1070 can further include a suture targetholder device or assembly 1080 (although called a suture target holderor assembly herein, this can be another type of target holder device orassembly to hold target devices/components for other procedures). Thesuture target holder 1080 can be physically coupled to one of themotorized actuators 1071, such as to distal extension arm actuatordevice of the plurality of actuators. The suture target holder 1080 canbe configured to hold or have mounted thereto a prosthetic heart valvedevice, or other prosthetic human implant device, which is desired to besutured. The suture target holder 1080 can have any suitable ordesirable shape, configuration and/or dimensions and can be configuredto hold or otherwise secure a target device or implant device in avariety of different ways. Example embodiments of suture target holderdevices and assemblies are described in detail below in connection withFIGS. 12-15 and 31. However, it should be understood that suchembodiments are provided as examples only, and other types of suturetarget holders can be implemented in the system 1000. In certainembodiments, the distal motorized actuator includes a rotating supportmember configured to rotate about a first rotational axis. In someembodiments, the suture target holder is coupled to the support memberof the distal motorized actuator and configured to rotate about an axisthat is parallel to the first rotational axis of the support member. Insome embodiments, the suture target holder is coupled to the supportmember of the distal motorized actuator and configured to rotate aboutan axis that is orthogonal to the first rotational axis of the supportmember.

FIG. 11 illustrates a perspective view of an exemplary embodiment of anautomated suture fixture 1170 in accordance with one or moreembodiments. The automated suture fixture 1170 includes a plurality ofmotorized actuators 1101, 1102, 1103, and 1104. The motorized actuators1101-1104 can be physically and/or communicatively coupled in a desiredconfiguration to provide a targeted range of motion and positioning fora distal actuator 1101 (referred to herein in certain contexts as adistal articulation arm) suitable for presenting a suturing targetdevice to an operator in accordance with embodiments of the presentdisclosure. While four motorized actuators are shown (i.e., 1101-1104),additional motorized actuators and/or other actuators could be used toprovide more degrees/types of movement and/or different types ofmovement (e.g., linear movement, movement in other patterns, etc.).FIGS. 18-25 and 28-30 illustrate exemplary configurations of automatedfixtures that include different arrangements of motorized actuators. Theautomated fixtures described herein with reference to these figures canmove up and down to different heights and articulate in additionaldirections, including horizontal directions.

An end or distal actuator can hold or comprise (or be modified to holdor comprise) a holder device or assembly (e.g., a holder device orassembly described herein with reference to FIGS. 12-15, and/or 18-31)and/or target device (e.g., valve). For example, the automated fixtureshown in FIGS. 18-25 and 28-30 (and other automated fixtures describedor shown herein) can be modified to include, at an end thereof, theholder assembly/device shown in FIGS. 26, 27 and/or 31. In someembodiments, bags can be configured to at least partially cover linkagesfrom ingress.

With reference to FIG. 11, each of the motorized actuators 1101-1104 cancomprise a base portion 1171 and a rotating support member 1177mechanically fixed to a rotor component 1105. In certain embodiments,the rotor component 1105 is associated with a magnetic motor (notshown), wherein rotation of the rotor component 1105 is caused by theinteraction between conductive windings and magnetic fields designed toproduce a torque around the rotor's axis (e.g., 1193 a, 1193 b, 1193 c,respectively). The motor can utilize a set of gears to rotate the outputrotor and a potentiometer at the same time. The potentiometer, which canat least partially control the angle of the servo motor, can allow thecontrol circuitry (not shown) to monitor the current angle of the servomotor. The motor, through a series of gears, can be configured to turnthe output rotor and the potentiometer simultaneously. The potentiometerfeedback signal can be fed into the servo control circuit, wherein whenthe control circuit detects that the position is correct, it stops theservo motor. If the control circuit detects that the angle is notcorrect, it can continue to turn the servo motor the correct directionuntil the angle is correct. While rotating actuators are described,actuators that move linearly can also be used (e.g., to raise and loweror move in and out a portion of the fixture).

In certain embodiments, the automated suture fixture 1170 includes aplurality of stages. For example, as shown, the fixture 1170 cancomprise a base stage 1172 that includes motorized actuators 1103, 1104.In the illustrated embodiment, the base stage 1172 includes two separateactuators (1103, 1104) that provide base support for the fixture 1170but it is to be understood that the number of motorized actuators can beany suitable number such as one, two, three, four, five, or more thanfive. In some embodiments, the actuators 1103, 1104 of the base stage1172 can be secured mechanically to one another in any suitable ordesirable way. For example, as shown, the actuators 1103, 1104 can eachbe mounted to a common reference structure, such as an attachment plate1189, or other structure. Each of the actuators 1103, 1104 can comprisea rotating support member (1177 c, 1177 d) configured to rotate about acommon rotational axis 1193 c, as shown.

The automated suture fixture 1170 includes a second stage 1173, whichcan comprise one or more motorized actuators. For example, as shown, thestage 1173 can comprise a single actuator device 1102 in someembodiments. The base portion 1171 b of the actuator 1102 can be fixedor secured to one or advantageously both of the rotating support membersof the base stage actuators 1103, 1104, as shown. Where the baseactuators 1103, 1104, are separated horizontally from one another by acertain distance, it may be desirable to use a support plate orstructure 1179 for fixing the support members of the base stageactuators 1103, 1104 to one another, wherein the second stage actuator1102 is fixed to the support plate 1179. That is, the support plate 1179can be secured or fixed, such as through the use of one or more bolts,screws, nuts, and/or the like, to both of the support members of thebase stage 1172, and further secured or fixed to the base of thesecond-stage actuator 1102 through any suitable or desirable means.

The second-stage actuator 1102 may further comprise a rotating supportmember 1177 b configured to rotate about the rotor axis 1193 b.Therefore, the second stage actuator 1102 can provide an additionaldegree of movement of the automated suture fixture 1170 when combinedwith the base-stage actuators in the attachment configurationillustrated. The automated suture fixture 1170 can yet provide anadditional degree of movement through implementation of the distalactuator 1101 illustrated. Although a third stage 1174 is shown in thediagram of FIG. 11, it should be understood that in certain embodimentsthe fixture 1170 can include only the base stage 1172 and the secondstage 1173. Furthermore, although the illustrated embodiment comprisesthree stages, it should be understood that embodiments disclosed hereincan be implemented using automated suture fixture assemblies having morethan three stages (e.g., 4, 5, 6, 7, 8 or more stages) and/or havingmore than four motorized actuator devices (e.g., 5, 6, 7, 8, 9, or moreactuator devices).

The distal third-stage actuator 1101 can be fixed or secured at a base1171 a thereof to the rotating support member 1177 b of the second-stageactuator 1102, as shown. Furthermore, the distal actuator 1101 canfurther comprise a rotating support member 1177 a, which can beconfigured to rotate to provide yet another degree of movement for thefixture 1170. In certain embodiments, the distal actuator 1101 can haveattached thereto (e.g., at the rotating support member 1077 a) a suturetarget holder assembly or target holder assembly in accordance withembodiments of the present disclosure.

The automated fixture 1170 is illustrated in the diagram of FIG. 11 in asubstantially erect arrangement, in which the respective support membersare positioned in a vertical arrangement, such that the rotational axesof the respective actuator devices lie substantially in a singlevertical plane. However, the additional degrees of movement provided bythe fixture 1170 may allow for rotation of the various support members,such that the axes of rotation of the respective rotors of the second-and third-stage actuator devices may ultimately lie in separate verticalplanes from the rotational axis of the support members 1177 c, 1177 d ofthe base-stage actuator devices 1103, 1104.

The various motorized actuator devices of the automated suture fixture1170 can be controlled in any suitable or desirable way. For example, insome embodiments, the various motorized actuator devices of the fixture1170 can be configured to receive wireless control signals over awireless connection with a control system, device or module, such as thecontroller 1030 of FIG. 10 described above, or the like. In someembodiments, the actuators can be configured to receive wired controlsignals, such as over the various wired connections 1191 illustrated.For example, certain embodiments, two or more of the stages and/oractuator devices of the fixture 1170 can be communicatively coupledusing a wired connection in a daisy-chain configuration, as describedherein.

FIGS. 18-25 illustrate an exemplary automated suture fixture 1970. Theautomated suture fixture 1970 includes an articulating arm 1978 having aplurality of actuator devices 1973A-1973D daisy chained together toprovide movement of a distal target mount point 1971. The distal targetmount point 1971 can be configured to secure a suture target holderdevice or assembly such as those illustrated in FIGS. 26, 27, and 31.The suture target holder can be physically coupled to the distal targetmount point 1971 or it can be integrally formed as part of the distaltarget mount point 1971. The suture target holder can be configured tohold or have mounted thereto a prosthetic heart valve device, or otherprosthetic human implant device, which is desired to be sutured.

The automated suture fixture 1970 also includes a vertical translationstage 1972 configured to vertically move the articulation arm 1978. Thisfurther increases the range of movement of the automated suture fixture1970 while maintaining a desirably small footprint. The verticaltranslation stage 1972 can include a piston configuration that attachesto the proximal actuator device 1973A so that the vertical translationstage 1972 can cause the entire articulation arm 1978 to raise andlower. The vertical translation stage 1972 can be configured to not beexactly vertical and can be tilted or angled away from perfectlyvertical.

The automated suture fixture 1970 can include a base or base plate 1979to support the vertical translation stage 1972 and to define a workspacefor manufacturing the target device. In certain embodiments, the workingzone for the fixture 1970 may be approximately 6.75″ high (e.g., thearticulation arm 1978 can translate about 6.75″ vertically or at least4″ and/or less than or equal to about 10″). In some embodiments, theheight of the vertical translation stage 1972, H, is about 26″ or atleast about 20″ and/or less than or equal to about 36″, at least about22″ and/or less than or equal to about 30″, or at least about 24″ and/orless than or equal to about 28″. In some embodiments, the depth of thebase plate 1979, D, is about 18″ or at least about 12″ and/or less thanor equal to about 24″, at least about 14″ and/or less than or equal toabout 22″, or at least about 16″ and/or less than or equal to about 20″.In some embodiments, the length of the base plate 1979, L, is about 20″or at least about 12″ and/or less than or equal to about 30″, at leastabout 15″ and/or less than or equal to about 26″, or at least about 18″and/or less than or equal to about 24″.

With respect to FIGS. 19 and 20, the illustrated positions of thefixture 1970 can correspond to a bottom of a stroke of the verticaltranslation stage 1972 in a z-direction. In certain embodiments, thedistal target mount point 1971 can be configured to tilt approximately54 degrees upward. With respect to FIGS. 21 and 22, the fixture 1970 canchange the position and orientation of the distal target mount point1971 while at the bottom of the stroke of the vertical translation stage1972. This can be done by actuating the articulation arm 1978.

With respect to FIGS. 23 and 24, the illustrated positions of thefixture 1970 can correspond to a top of a stroke of the verticaltranslation stage 1972 in the z-direction. In certain embodiments, thedistal target mount point 1971 can be configured to tilt approximately15 degrees down from horizontal. With respect to FIG. 25, theillustrated position of the fixture may represent an approximately45-degree downward tilt for implementing a “dipping” step.

FIGS. 28 and 29 illustrate another example automated suture fixture 2870having a different configuration for an articulation arm 2878. Thefixture 2870 includes a plurality of actuator devices 2873 that areoriented to provide additional vertical support. By orienting rotors sothat the axis of rotation is substantially vertical, the support memberscan provide additional support against downward forces as opposed torelying on the motor to resist downward forces. This may be of increasedimportance closer to the proximal end of the articulation arm due to theincrease in torque the further from the pivot point a force is applied(e.g., a downward force at a distal end of the articulation arm 2878 cancause more torque at the proximal end than at the distal end). Theautomated suture fixture 2870 can be coupled to different targetholders, such as target holders 2880 a and 2880 b respectivelyillustrated in FIGS. 28 and 29. The target holder 2880 a can be the sameas or similar to the target holder 3180 described herein with referenceto FIG. 31. The target holder 2880 b can be geared (e.g., similar totarget holder 2680) to allow for rotation of the target holder and/ortarget without blocking the view of the visualization system. The targetholder 2880 b is also beneficially configured to allow access to theinterior of the target from both ends or leave the interior open on bothends so that an operator can insert a finger and/or retrieve a needlefrom inside at either end of the target.

FIG. 30 illustrates another example automated suture fixture 3070 havinga different configuration for an articulation arm 3078. The articulationarm 3078 has a crane-like configuration and is configured tosubstantially enclose the actuation devices within a housing or aplurality of housings. The articulation arm 3078 secures a targetassembly 3080 that is similar to the target assembly 3180 describedherein with reference to FIG. 31.

Suture Target Holder

FIG. 12 illustrates an articulation arm 1878 coupled to an exemplaryholder component 1880 according to one or more embodiments. Thearticulation arm 1878 can be the same as or similar to the articulationarms 778, 878 described herein with reference to FIG. 7A, 7B, 8A, 8B, or8C and/or one or more actuators described or shown elsewhere herein. Theholder component 1880 can be the same as or similar to other targetholder components, devices, or assemblies (e.g., 771, 880, 1080, 1180,1380) described elsewhere herein. In certain embodiments, the holdercomponent 1880 can be fixed or secured to the distal articulation arm1878 or end actuator of an automated suture fixture for the purpose ofproviding an interface for securing an implant device or other targetform or device. The holder component/assembly 1880 can be designed orconfigured to hold or secure an implant device or other target device,or portion thereof, for the purpose of allowing suturing thereofaccording to any process or embodiment disclosed herein.

The holder component 1880 can be configured to secure or otherwiseinclude a cylinder form 1885, which can be sized or dimensioned to havepulled thereover the target device or implant (e.g., a fabric-coveredsupport stent for a surgical valve implant device 1818). For example,the valve implant device 1818 may comprise a plurality of commissurepost portions 1892, as shown, which may be positioned such that they areoriented in a direction towards the holder component 1880, such that aseam 1818 may be stitched above what will ultimately represent an inflowedge of the implant device 1818. The cylindrical form/component 1885 maybe designed in a similar manner to a handheld implant device holder,which may be used in certain embodiments in executing suturingprocedures without the assistance of the articulation arm 1878 andassociated components. The cloth 1825 can be disposed about a rigidwireframe structure, wherein the seam of stitches 1818 is executed inorder to substantially cover the wireframe with the cloth 1825. The seam1818 can secure the cloth 1825 about a stiffening band, as describedherein with reference to FIG. 3A.

The holder component 1880 can be designed for a particular application,such as for a transcatheter heart valve suturing application, or asurgical heart valve suturing operation, or other implant suturingprocedure. The valves can be for animal (e.g., for human) use. Althougha surgical valve configuration is shown in FIG. 12, it should beunderstood that the holder device 1880 and/or other components of FIG.12 may be designed or configured to support suturing processes and/orother processes for a transcatheter heart valve or other valve or otherdevice. For example, while the diagram of FIG. 12 illustrates acylindrical form 1885 designed to hold the implant device 1818 in adesired position, such cylindrical form may not be necessary withrespect to a transcatheter heart valve. For example, in place of thecylindrical form 1885, the holder 1880 can instead be configured tosecure a rigid cylindrical wireframe of a transcatheter heart valve, anembodiment of which is illustrated and described above in connectionwith FIG. 1.

With the target or implant device 1818 secured to the holder device1880, an operator may conveniently be able to execute stitchingoperations using, for example, a needle 1809 and thread 1817. Forexample, the system can facilitate or make it easier for an operator toperform exterior circumferential stitching operations (e.g., withrespect to surgical heart valves), interior-to exterior stiches, and/orexterior-to-interior stitches (e.g., for certain transcatheter heartvalve stitching operations). The holder device 1880 and/or associatedcomponents can be designed to efficiently allow for the target orimplant device 1818 be presented to the operator such that multipledegrees of freedom are available for the operator and articulation arm1878 to further simplify and assist with suturing or other procedures.

In certain embodiments, the holder component 1880 and/or one or morecomponents associated with the holder component 1880 (e.g., the cylinderform, etc.) can be configured to rotate about a central or longitudinalaxis 1893 thereof. Central axis 1893 can represent a central axis of thetarget or implant device 1810, cylinder 1885, and/or other portion ofthe holder component 1880 (e.g., when the device 1810, cylinder 1885,and/or other component is connected or mounted to the holder component1880). The rotation of the holder component 1880 and/or componentsassociated therewith may allow for presentation of different surfaceareas of the target or implant device 1810 to the operator duringdifferent stages of a suturing procedure or other procedure.

The specific type of holder that is utilized for a procedure orapplication (e.g., for a suture assist application) may be determined ona process-by-process basis. That is, specific adapters may be suitableor desirable for each of separate operations/procedures, or for separatetypes of valves or other targets. In certain embodiments, a singlesuturing procedure of an implant device can involve use of multipledifferent types of holder devices.

FIG. 13 illustrates an exemplary holder component/device 1180 inaccordance with one or more embodiments disclosed herein. For example,the holder device 1180 may be the same as or similar in certain respectsto the holder device 1880 described herein with reference to FIG. 12and/or other holder devices, components, assemblies, etc. (e.g., 771,880, 1080, 1380) described elsewhere herein. The holder component 1180can comprise one or more features or components designed to allow for acylindrical holder and/or component of a target or implant device to besecured thereto. For example, the holder 1180 may allow for securing ofa cylindrical holder and/or component of the implant device in such amanner as to provide radial symmetry for precise positioning thereof. Incertain embodiments, the holder 1180 comprises a plurality of jaw orclamp forms 1135, which may be arranged in a radially symmetricalpattern about a circumference of the holder 1180. The jaws 1135 may beconfigured to be tightened to hold the cylindrical holder and/or targetor implant device component or may comprise one or more other mechanismsfor securing the cylindrical holder and/or target or implant deviceabout a central hub component 1139. For example, the jaw forms 1135 maycomprise one or more apertures for utilizing set screws therein, whichmay be configured to grip or secure the cylindrical holder and/or targetor implant device component.

FIG. 14 illustrates an implant device fit about a cylindrical holder1285, the implant device comprising a plurality of commissure posts 1292formed of a frame (e.g., a wireframe) (not shown), wherein the frame orwireframe is at least partially covered by a cloth 1225, the cloth 1225being sutured to secure the cloth 1225 about the frame structure of theimplant device 1210. FIG. 14 illustrates an exemplary back stitched seam1218 that can be implemented to secure the cloth 1225 about the supportstructure, but other types of stiches and seams could also oralternatively be used. Although wireframes are described in detail andused as examples of frames herein in connection with certain surgicalvalves, it should be understood that any type of stiffening or supportframe forms or components may be utilized, e.g., to provide thedescribed commissure posts and/or stiffening bands associated withcertain surgical valve devices. For example, one or more plastic bands,metal bands, or other stiffening or rigid support structures can be usedto form the, sure posts and/or stiffening band of a surgical valve. Asshown in FIG. 14, suturing of certain implant devices may involveutilizing temporary stitches that can be removed upon completion ofcertain stitched seams or other suturing operations.

Gimbal Mount Holder

Certain embodiments disclosed herein provide for holding and/orpositioning of an implant device that is the subject of a suturingprocedure using a gimbal-type holder assembly 1380, as shown in FIG. 15.Further, the automated fixture, articulation arm, and/or variousactuators of the automated fixture can also or alternatively beconfigured to function similar to a gimbal. While certain embodiments ofimplant device holder components as disclosed herein may generallypresent one end of the implant device and/or circumferential surfaces orfeatures of the device to the operator, certain of such embodiments maynot allow for free operation by the operator about both front and backends of the implant device and/or holder device. For example, one end ofthe implant or holder device may be secured at least in part to acomponent of an articulation arm and/or other holder device. The valveholder device of FIG. 15 and/or other portions of the automated fixturecan provide a mount that allows for operational access at multiple endsof an implant device, and may essentially be configurable to float orrotate to the proper position for manufacturing, thereby relieving theoperator of the burden of removing the implant device from the holderand rotating and re-securing the implant device in order to have accessto both ends of the implant device during a suturing procedure or otherprocedure.

The gimbal assembly 1380 and/or other gimbal-like arrangements of anautomated fixture can be configured to articulate a heart valve or othertarget or implant device to substantially any desired orientation forease of access and use for an operator. For example, the gimbal assembly1380 can comprise a three-axis gimbal allowing for three degrees offreedom. Furthermore, where the gimbal assembly 1380 is mounted to anarticulation arm and/or device, additional degrees of freedom may beprovided. For example, the combination of the gimbal assembly 1380 withthe associated automated suture fixture can provide six degrees offreedom of manipulation. In certain embodiments, the gimbal assembly1380 may be a two-axis gimbal.

When having secured thereto a target or implant device, such as atranscatheter heart valve or surgical valve implant device, the gimbalassembly 1380 and/or other gimbal-like arrangement of an automatedfixture can be configured to position the target or implant deviceaccurately in multiple orientations. For example, the gimbal assembly1380 can be configured to execute circumferential rotation of a heartvalve, while maintaining the outer surface (or a desired portion of theouter surface) of the target or implant device or valve within a focalplane or depth of field of an associated camera and/or magnificationsystem.

The gimbal assembly 1380 includes a cylindrical implant holder 1385having disposed thereon a surgical implant device 1310, which mayrepresent a suturing target implant in accordance with certainembodiments. However, although a cylindrical implant holding form 1385is illustrated in FIG. 15, it should be understood that, in certainembodiments, the gimbal assembly 1380 may not include the cylindricalimplant holding form 1385, and can instead be configured to hold adifferent holder component (e.g., a rigid cylindrical orotherwise-shaped component) or to directly hold a heart valve or othertarget or implant device or portion thereof, such as a cylindricalwireframe of a transcatheter heart valve as described herein. Adifferent holder component or target or implant device could be heldwhere the cylindrical holder 1385 is shown. For purposes of discussion,the illustrated component or cylinder 1385 may be referred to below as aholder component and/or as the target or implant device (or valve)itself, indicating that the target or implant device to be sutured, orotherwise engaged, can be disposed and/or secured in the same positionshown by the disposition of the cylinder 1385 in FIG. 15. Descriptionsof the component 1385 apply to any holder or target device held in theposition of component 1385, regardless of whether it is referred to as acomponent, device, holder, valve, etc. in the description.

Rotation of the target or implant device or valve 1385 may beimplemented by rotating a hub component 1382, which can be attached orassociated with a rotating servo head of an articulation arm or actuator(not shown in FIG. 15), wherein the hub component 1382 can be associatedwith an arm component 1383 that allows for rotation of the target orimplant device or valve 1385 about a central or rotational axis 1301 ofthe hub component 1382 and the target or implant device 1385. That is,where the target or implant device or valve 1385 is connected to the arm1383 via a connector form 1388, such as a Y-connector form, it may bedesirable for the connector form 1388 to be adjusted such that thecentral or longitudinal axis of the target or implant device is alignedor substantially aligned with the rotational axis 1301 of the hubcomponent 1382. When the target or implant device 1385 and the hubcomponent 1382 are thus aligned, rotation of the hub component may bepossible while maintaining coaxial alignment of the target or implantdevice 1385 with the hub 1382, thereby allowing for consistentpresentation of an outer surface or region of the target or implantdevice 1385 in the depth of field of the associated visualization system(e.g., camera). Therefore, the target or implant device 1385 can becircumferentially rotated without moving the target or implant device,or target suture position thereof, out of focus of the camera system.

The connector form or Y-connector 1388 can be configured to nest in abase portion of the arm 1383 and can further be adjustable and providean indexing feature to allow for movement in and out of the basecomponent 1389 to thereby allow for precise positioning of the target orimplant device 1385. In certain embodiments, the hub component 1382 maybe coupled magnetically with an associated articulation arm or actuatorof an automated fixture. Optionally, the connector form or Y-connectorcan be rotatable within the base component 1389 to provide for moredegrees of movement and positioning possibilities (e.g., to allow thetarget device to be flipped toward or away from the hub component 1382and/or rotated to any angle with respect to the axis 1301. The basecomponent 1389 may include a motor or be a motorized actuator to causemovement or rotate the connector form or Y-connector 1388, e.g., so thesystem can be programmed or scripted to move automatically to a desiredposition/rotation for a procedure.

The automated fixtures and/or holders described herein can be configuredsuch that a point (e.g., a centermost point) within a target device canremain fixed/stationary while the target device is rotated orrepositioned to expose different portions of the target device for aparticular operation/step in a procedure.

While various other multi-axis gimbal devices may not be designed tohave manufacturing done to them, the gimbal assembly 1380 shown in FIG.15 can advantageously provide for precise positioning of the distal endof the connector form or arm 1388 and the target or implant device 1385in order for manufacturing to be performed thereon. Furthermore, withone or two side points of attachment 1386, multiple degrees of freedomcan be presented by the gimbal assembly 1380, thereby providingconvenience and ease-of-use for the operator. With the multiple-axis(e.g., three-axis) functionality of the gimbal assembly 1380 or othergimbal arrangement of the automated fixture, the target or implantdevice can be allowed freedom to move to a wide variety of positions andangles to make it easier for the operator to engage with (e.g., suture,inspect, etc.) the target or implant device or valve and to maneuverfingers or other items at a desired location thereon. The multiple-axis(e.g., three-axis) functionality can also make it easier for an operatorto view from one side through to the other side of the target or implantdevice 1385 without substantial obstruction.

Geared Mount Holder

FIG. 26 shows an exemplary mount or holder assembly 2680 that can beused with the assist systems, automated fixtures, gimbal assemblies orarrangements, etc. disclosed herein. The holder device 2680 can beattached or connected to another holder and/or to a motorized actuator(e.g., the same as or similar to those discussed or shown elsewhereherein), e.g., at a proximal end, distal end, back end, end opposite therotating portion or ring, etc. The holder assembly 2680 can comprise amotor and/or motorized actuator (e.g., a rotational motor/motorizedactuator). The holder assembly 2680 can include a portion 2681 ormechanism configured to hold and rotate a target device (e.g., heartvalve).

FIG. 27 illustrates an exemplary holder ring 2681 that can be used tohold and to rotate a target device (e.g., a heart valve). The holderring 2681 can include a geared portion 2686 (e.g., with gear teeth) orother interlocking or friction-engaging portion, etc. that can interactwith another gear 2683, interlocking component, friction-engagingcomponent, etc. to cause rotation of the holder ring 2681. The othergear 2683, interlocking component, friction-engaging component, etc. canbe connected to a drive shaft (not shown). The drive shaft can connectbetween a motor and the other gear 2683, interlocking component,friction-engaging component, etc. such that the motor can cause thegear, interlocking component, friction-engaging component, etc. torotate. Rotation of the gear 2683, interlocking component,friction-engaging component, etc. can cause the holder ring 2681 torotate.

The holder ring 2681 can include an inner surface 2682 configured tohold and engage the target device. Though, in one embodiment, the outersurface can be configured to hold and engage the target device with thetarget device fitting over and around the outer surface. Features 2687can be included on the inner surface 2682 (or outer surface) to improvethe hold or better secure the target device. The holder ring 2681(and/or its inner surface 2682) can be configured to cover only a smallsurface area of the target device, e.g., to leave portion of the targetdevice to be operated on, treated, sutured, etc. open and unobstructed.The interior of the target device can beneficially be left accessibleand open from both ends to allow an operator access from either end tothe interior of the target device. Using a rotating holder assembly 2680allows an automated fixture to rotate a target device without having torotate the entire holder assembly. This allows the automated fixture tokeep the target device (e.g., a portion of the target device or surfacethereof) within a depth of field of a visualization system (e.g., acamera) throughout 360-degree rotation of the target device withoutrequiring movement of the visualization system or adjustment of thefocus, and without ever having an arm or other portion of the holderassembly 2680 rotate into the visualization system's (e.g., camera's)view.

While an exemplary implementation is shown in FIGS. 26 and 27, otherimplementations of the concepts described are also possible that mayinclude additional elements or components, different elements orcomponents, or not include some elements or components.

Example Extended Holder Assembly

FIG. 31 illustrates another example holder or holder assembly 3180 thatextends distally from an articulation arm to allow access to an internalportion of a target device (e.g., a valve) from both an in-flow end andan out-flow end of the target device. In other words, the holderassembly is configured such that it does not block or leaves open theends. The holder assembly 3180 includes a support arm 3181 that extendsfrom a base 3182 that couples to an articulation arm, examples of whichare described herein. In some embodiments, the articulation arm and/orbase 3182 are configured to rotate about a central or longitudinal axisof a support 3183 (e.g., a cylinder support) of the holder assembly3180. The support 3183 is coupled to the support arm 3181 and isconfigured to secure the target device to the holder assembly 3180 inthe same or similar manner as other holder assemblies described herein.

Point-By-Point Suture Assistance

Embodiments disclosed herein provide for systems, devices, and methodsfor providing point-by-point assistance (e.g., point-by-point sutureassisting) functionality in connection with procedures (e.g., thesuturing of implant devices, inspection, or other procedures). Forexample, a suture assist system in accordance with the presentdisclosure may provide point-by-point (e.g., step-by-step) assistance toan operator through the use of one or more of an automated suturefixture, a visualization system (e.g., a microscope and/or magnificationsystem, and/or an image display system), and/or other associatedsystems, devices, or components. FIG. 16 illustrates a flow diagram ofan exemplary process 1600 for training/programming a system to implementand/or facilitate implementation of a particular procedure. For example,the steps in the process 1600 can be used to train/program a sutureassist system to implement a suture assist procedure or suturingprocedure according to one or more embodiments. The process 1600 mayprovide a programmable process, wherein a computing system, incombination with hardware systems as disclosed herein, can be configuredto read positioning of an automated fixture or automated suture fixture,store position information according to a desired script or program,and/or play the stored script/program back for the purpose of allowingan operator to execute the procedure associated with the script/program.The process 1600 may allow for relatively easy programming of the sutureassist procedure script/program through the positioning and/or recordingof positioning of an articulation device and/or visualization system(e.g., a microscope or camera system). For example, at block 1602, theprocess 1600 may involve an operator manipulating an automated fixtureor automated suture fixture to a desired position associated with afirst step of an implant suturing procedure or other procedure inaccordance with the present disclosure. For example, the operator mayexert or cause to be exerted torque or other force on one or moreportions of the automated fixture or automated suture fixture, such asan articulation arm or distal end portion thereof to bring the distalend into a position associated with a suturing operation or otheroperation or step.

The automated fixture or automated suture fixture can be manipulatedand/or repositioned in any suitable or desirable manner. For example, incertain embodiments, the operator can manually manipulate at least aportion of the automated fixture or automated suture fixture, such as anarticulation arm thereof, to a desired position. In certain embodiments,manipulation of the automated fixture or automated suture fixture and/orarticulation arm thereof can be effected through the use of a controlsignal, which can be generated using a joystick, buttons, or otheroperator input device, or through the use of any type of softwarecommand/instruction entry or other programming (e.g., using numericposition representation), or the like. In certain embodiments,manipulation of the automated fixture or automated suture fixture can beachieved through the manipulation of a corresponding fixture which canbe configured such that movement or manipulation thereof is at leastpartially mirrored by the automated fixture or automated suture fixture,or wherein the automated fixture or automated suture fixture isconfigured to be repositioned in response to movement of the mirroringdevice or system.

In certain embodiments, the process 1600 can involve focusing avisualization system (e.g., a camera or magnification system) to atarget position or point associated with the automated fixture orautomated suture fixture, such as to a portion of a target or implantdevice that may be held or secured by the automated fixture or automatedsuture fixture. However, it should be understood that in certainembodiments, camera focusing may not be required where the process step1602 involves manipulating the automated fixture or automated suturefixture in order to bring the target position into focus with astationary visualization system or a camera. That is, the manipulationof the automated fixture or automated suture fixture in step 1602 caninvolve proper placement of the target implant device, or target portionthereof, into the focal plane of the camera or magnification system, asdesired.

At block 1606, the process 1600 can involve capturing the positioninformation associated with the manipulated automated fixture orautomated suture fixture, or portion thereof, as executed in accordancewith process step 1602. For example, capturing the position informationmay involve saving one or more values or data representative of aposition of the automated fixture or automated suture fixture and/orportion thereof, and/or positioning or focusing of the visualizationsystem (e.g., camera or magnification system).

At block 1608, the process 1600 can involve storing the positioninginformation in connection with the procedure associated with theposition of the automated fixture or automated suture fixture. Theposition information can be stored along with or beassociated/correlated with additional metadata indicating variousparameters associated with the position information, such as operatorinformation, patient information, timing information, or the like. Theadditional metadata or other information can be stored, associated, orapplied to the script at the time the positioning information is storedin step 1608. Also, the script can be stored without the additionalmetadata or other information in step 1608, and the additional metadataor other information can optionally be applied to the script at a latertime, e.g., to customize the script for different operator, for exampleto allow adjustment of the script positioning to accommodate operatorsof different sizes/heights or other characteristics (e.g., to flip thescript positioning for left vs. right handed operators).

At decision block 1610, the process 1600 can involve determining whetheradditional steps of the procedure remain to be programmed, or whetherthe position programmed in the preceding steps represents a finalposition or whether the set of positions programmed previously representa full set of steps of the procedure. If so, the process 1600 can cometo an end, as represented by block 1612. If additional positions orsteps in the procedure remained to be program, the process 1600 canproceed back to block 1602, where an additional positioning of theautomated suture fixture can be programmed in accordance with blocks1602 through 1608. In certain embodiments, the storing processrepresented at block 1608 may not be performed until after all steps ofthe procedure have been programmed. In certain embodiments, each of themanufacturing steps or positions of the automated suture fixture and/orcamera/magnification system can be recorded in sequential order in orderto retain such order when playing back the stored procedure. In certainembodiments, where operator-specific metadata is recorded in connectionwith the process 1600, different operators may be able to store modifiedversions of the procedure that are specific to the particular operator.That is, an individual operator may be able to train the implantarticulation system to his or her desired ergonomics or preferences.Optionally, individual operator information (e.g., profiles) can beapplied at a later time to a process script to adjust the script toindividual operator characteristics and/or preferences.

In certain embodiments moving from one step of the process 1600 toanother, or looping back to program a new position at block 1602, can betriggered through the use of a foot pedal, other operator-inputtriggered device, voice commands, and/or other electronic input.

FIG. 17 illustrates a process 1700 for executing a suturing procedureaccording to one or more embodiments. While described in terms of asuturing procedure, similar steps can be used for other procedures(e.g., for inspection procedures, other treatment or processingprocedures, etc.) For example, the process 1700 can be performed after asuture assist system has been preprogrammed with a certain procedure,program, or script, such as can be created using to thetraining/programming process 1600 described above in connection withFIG. 16. One or more computer components, such as one or more processorsand/or memory devices, can be utilized to store and execute aprocedure-directing script/program, such that a procedure script/programcan be played back for an operator on-demand.

At block 1702, the process can involve loading a pre-programmed suturingprocess script or program, which may have been previously programmed inconnection with the training/programming process as described above. Thedesired script/program can be loaded in various ways, e.g., by providinginput to the system or a computer of the system to load the desiredscript/program from storage or memory (e.g., stored memory, internalmemory, external memory, portable memory, disk, thumb drive, download,etc.), loading the desired script/program from an external source,inputting or providing a code (e.g., scanning a barcode on the targetdevice or materials associated with the target device) such that thesystem automatically loads the correct script/program for the targetdevice (e.g., based on the input code, scanned barcode, etc.), providingvoice commands to load a script/program, and other ways of loading thedesired script/program. In certain embodiments, the process 1700involves selectively loading either a right-handed or left-handedversion of the process script based on a preference of the operator orbased on an operator profile, or applying operator information to ascript to adjust the script to individual operator preferences (e.g., toflip the script positioning for left vs. right handed operators, toadjust positioning for other operator characteristics, for example,size, height, etc.). In certain embodiments, the operator may alternatebetween right- and left-handed versions as desired, even mid-procedure,which may beneficially allow the operator to rest a fatigued hand, forexample. This could be done by applying different information orparameters to the script at different times.

At block 1704, the process involves triggering the positioning of anautomated suture fixture (or automated fixture) and/or associatedvisualization system (e.g., camera or magnification system) to a currentprocess position associated with a current step of the suturingprocedure or other procedure. It should be understood that in certainembodiments, performance of step 1704 does not involve positioning, ortriggering the positioning of, a visualization system or a camera. Forexample, an associated camera or other visualization/imaging system canbe substantially static, wherein the articulation device controlspositioning of the target device at the proper focus or focal length forthe visualization/imaging system or camera. The triggering of theautomated suture fixture can be input or implemented in a suitable ordesirable manner. For example, the operator can activate a foot pedal,other switch, physical trigger button, mechanism, voice command, and/orelectronic input (e.g., a touchscreen icon/button, etc.) in order totrigger the set-up of the suture assist system to the next step in thesuturing procedure.

At block 1706, the process 1700 can involve identifying a target sutureposition or other position (e.g., inspection position, other treatmentor processing position, etc.) on a monitor display. For example, thetarget suture position may be identified using one or more visual aidsor reticles, or the like, as described above. In addition,identification of the target suture position may be achieved usinginstructions, or other visual overlays, examples, and/or guidancedisplayed on the monitor display. The target position can be identifiedby the operator (e.g., by clicking on a target position, dragging avisual aid to the target position, entering coordinates, or in otherways), and/or the target position can be identified by the script orprogram automatically to sense and/or indicate where the next step,operation, suture, inspection, etc. should occur.

At block 1708, the process 1700 can involve executing a suturingoperation or other operation or step using the monitor display (or othervisualization system viewing area) as guidance. For example, thevisualization system (e.g., the monitor display, in combination with theoperation of an associated camera or magnification system), can presentthe target suture position in focus, wherein the operator may visuallyevaluate the suturing position and execution of the operation/step usingthe monitor display (or other visualization system viewing area).

Once the suturing operation or other operation/step has been executed atblock 1708, if the relevant suturing operation or other operation/steprepresents a final operation/step of the suturing procedure or otherprocedure, the process 1700 may end as shown at block 1712. However, ifadditional steps of the suturing operation/procedure or other operationor procedure remain, the process 1700 may return to block 1704, where asubsequent step of the suturing process or other process may betriggered, such that the process 1700 may involve completion ofsubsequent step(s). In certain embodiments, the process 1700 may involvecapturing an image of the suture target prior to the repositioning ofthe automated suture fixture. For example, image capture can betriggered by user input or other event indicating the completion of astep of the process 1700. Such captured images can be used for a varietyof purposes including training and inspection. Optionally, the entireprocedure can be recorded (e.g., as a movie file) for training,inspection, quality control, and/or other purposes. Bookmarks orindicators can be stored at times when an operation/step is completed toallow an operator, supervisor, or other person to jump through the videoto key times/frames, e.g., for inspection, training, or other purposes.Additionally, the images, video, frames, etc. can be sent/transmittedand graphically displayed on another device (e.g., phone, computer,mobile device, etc.), e.g., sent to a device of a manager and/or qualitycontrol person for review.

Where the suture assist system has been programmed to implement, ordirect the implementation of, a suturing procedure or other procedure,such procedure may be repeatable over many iterations, thereby providingimproved efficiency and completion of procedures (e.g., improvedsuturing of implant devices).

In certain embodiments, the process 1700 can allow for the operator tomake modifications at a given step of the suturing procedure to thepositioning of the automated suture fixture and/or camera system inorder to further customize such step. In certain embodiments, suchaltering by the operator can be programmed back into the proceduralscript executed by the suture assist system in connection with theparticular procedure, such that future execution of the procedure canincorporate the modifications implemented by the operator during theprocess 1700. Furthermore, in certain embodiments, the process 1700 canallow for the operator to temporarily pause the process 1700 prior tocompletion thereof. For example, the operator may wish to step away fromthe operating environment, such as for a break or other purpose, whereinthe process 1700 can allow for the operator to reinsert him or herselfinto a stage of the process at which the process was paused. Therefore,such availability of pausing and reentering the process may allow forthe operator to reduce strain or burden associated with prolongedengagement with the suture assist system.

Certain suturing procedures (or other procedures) may involve suturing(or other processing, treatment, etc.) of implant devices that havecertain requirements with respect to moisture and/or other parametersassociated with one or more components of the implant device. Forexample, with respect to prosthetic heart valves, suturing operations orother operations associated with valve leaflets may require that suchleaflets not become dried out, because drying out can adversely affectthe physical properties thereof. For example, where the valve leafletscomprise biological material, such as pericardial leaflets, it may benecessary or desirable to periodically expose such leaflets to moisture,such as in the form of a liquid solution, gas, or the like. In certainembodiments, the process 1700, and/or other processes or proceduresdisclosed herein, can be implemented in connection with a mechanism forallowing the operator or system (e.g., an automated portion of thesystem) to periodically, or on an as-needed basis, moisturize one ormore components of the implant device being sutured. For example, thesystem can allow the operator to immerse or otherwise saturate or coverat least a portion of the implant device in, for example,glutaraldehyde, or other or liquid. In certain embodiments, anarticulation arm in a suture assist system can be configured toimplement, as part of an automated procedure, the dipping or immersion,spraying, or other means of exposure, of an implant device or portionthereof in a moisturizing solution. For example, such immersion or othertype of moistening of the implant device can be performed substantiallyautomatically and may or may not require engagement by the operator. Incertain embodiments, a timer can be implemented in connection with asuturing procedure in accordance with the present disclosure, whereinthe timer indicates and/or notifies an operator of moisturizingrequirements for an implant device being operated on. For example, withrespect to the process 1700 of FIG. 17, an interrupt routine may beimplemented which is designed to interrupt the operator and/or theprocess executed by the suture assist system when it is determined thatit is necessary or desirable for the operator to moisturize the implantdevice or portion thereof. In certain embodiments, sensors, light,lasers, and/or other techniques can be used to detect the moisture levelor other characteristics of the target or implant device or leaflets. Incertain embodiments, the process 1700 may not continue until theoperator has performed the moisturizing step, or alternatively thearticulation positioning device that holds the implant device mayexecute the moisturizing operation in response to the interrupt routine.

Suture Tension Management

Certain embodiments disclosed herein provide for systems, devices andmethods for assisting in suturing operations through the use oftensioning functionality, which may be useful with respect toimprovement in quality, efficiency, and/or quality control evaluation.For example, where suturing involves passing a needle through one ormore layers of material of an implant device, varying pinch forces maybe required in order to penetrate the layers with the proper amount oftension. Certain systems involve the use of an automated suture fixturethat is designed to present to the operator varying tension settings inone or more stages of the articulation device, such as at anarticulation arm or at a base of the automated suture fixture. Thetension management of the system may promote consistent force of needlesand puncturing certain materials of the implant device and can be usedin combination with an automated needle delivery system to therebyimprove the tensioning execution by the automated needle deliverysystem.

In certain embodiments, tension management can be implemented throughthe use of a pressure-sensitive pressure plate, device, or structure,which can be disposed on or in physical contact with a base portion ofthe automated suture fixture, or other portion of the automated suturefixture. The pressure sensitive device can be configured to provide areadout of tensions experienced by the automated suture fixture, whichmay indicate whether the operator has exacted excessive torque orpressure on the implant device, or not enough force, which may providean indication of quality of operator performance.

Articulation and/or tensioning of the articulation arm may be designedto present a desired sewing angle or sewing tension and/or resistancefor a specific stitch. Tensioning of the articulation arm or othercomponent of the automated suture fixture may provide controlled pinchforces for penetrating, for example, heart valve implant deviceleaflets. Tension management may be used to provide consistent force forneedle delivery, wherein tighter tension may be desirable for certainpunctures, while looser tension may be desirable or others.

Fully Automated System

In certain embodiments, a fully or mostly automated system can be used.The fully or mostly automated system can include one or multipleautomated fixtures (e.g., one, two, three, four, five, six, or more thansix automated fixtures). For example, a first automated fixture (whichcan be the same as or similar to the automated fixtures or automatedsuture fixtures described and shown herein) can be used to articulateand move an implant device to various desired positions for processingoperations/step (e.g., suturing, treatment, applications, etc.), while asecond and/or third automated fixture or device can be used to performthe processing operations/steps at the various desired positions. Forexample, a second automated fixture could act similar to a sewingmachine that moves a needle in and out (e.g., which can be done in asingle path, in a single plane, along a linear path, in two-dimensionalspace, in three-dimensional space, etc.) to add the sutures to a targetor implant device while the first automated fixture moves the target orimplant device to the correct position to receive the desired suture inthe correct location on the target or implant device. In variousembodiments, a second automated fixture and a third automated fixturecan work together to move and to receive a needle in a sewing operation,e.g., passing the needle from the second fixture to the third fixtureand from the third fixture to the second fixture after passing theneedle through the desired portion of a target device held as the targetdevice is moved to the desired positions by the first fixture, etc.Suture tensioning management could also be used, which could, forexample be similar to that described herein to maintain and to useproper tensioning and pressure in the suture, needle, cover, and/orother materials. Optionally, the second automated fixture (and/or anadditional third automated fixture and/or more fixtures) could beconfigured and used to apply another material (e.g., a polymer, coating,or other material) to the target or implant device (e.g., the fulldevice or a portion thereof) without suturing, e.g., in a sputteringprocedure, electrospinning procedure, treatment procedure, coatingprocedure, and/or other procedure.

A mostly automated system, as used herein, can include systems thatutilize minimal operator input, such as controlling when to proceed to anext step in the process, repeat a step in the process, pause during orafter a step in the process, and the like. Mostly automated systems mayalso utilize operator input to verify when a step is performed correctlyby the system before proceeding in the programmed process. Similarly, amostly automated system can include an operator that modifies orotherwise manipulates the pre-programmed process during the procedurebased on one or more manufacturing considerations. Mostly automatedsystems may also allow but not require operator input in any of thesituations described herein.

The disclosed automated systems may be programmable such that multiplefixtures can be coordinated with each other to follow or to implement apreviously specified or programmed operation on a target device (e.g.,one or more previous specified or programmed sewing pattern(s) for aheart valve). The systems may then step through the programmed operationwith or without operator intervention.

In some embodiments, one of the automated fixtures can be a multi-axisrobotic arm with a needle handling component, which can be configured toperform sewing operations, replacing steps or procedures typicallyperformed by hand in the manufacture of an implant device. Inconjunction with one or more other automated fixtures (e.g., otherautomated fixtures disclosed elsewhere herein, such multi-axis roboticarms), can be configured to maneuver a needle to suture an implantdevice according to a procedure script (e.g., a pre-programmed suturingprocedure script or suturing script). In certain implementations, theimplant device can be sutured using the robotic arms or suturing armswithout intervention of a human operator (or with only occasionalintervention such as 1-10 times a day) during the manufacturing process.

In certain embodiments, a fully automated suturing system can includetwo automated fixtures configured as dual coordinated suturing armsconfigured to suture an implant device in conjunction with a thirdautomated suture fixture for manipulating or moving the suture target,examples of which are described herein. The fully automated suturingsystem can suture an implant device based on a pre-programmed suturingprocedure, examples of which are described herein. Each suturing arm caninclude a component at a distal end of the arm configured for handlingand transferring a needle from one arm to the other (e.g., one or moreneedle holders). The fully automated suturing system can be configuredto provide positional targeting of sutures on the implant device. Thisallows coordination of movements between suturing arms and the automatedsuture fixture holding the suture target during a suturing procedure.The fully automated suturing system can include a targeting systemconfigured to provide feedback to the system for targeting the needle inthe placement of sutures. For example, the targeting system can includea camera that allows image analysis programs to determine a targetedneedle location for specified stitch points on the implant device beingmanufactured. The fully automated suturing system can be configured toutilize single-tipped needles (e.g., a needle with a single pointed endand an eyelet on the opposite end to hold the thread) or double-tippedneedles (e.g., a needle with both ends being pointed and an eyeletbetween the tips to hold the thread). In some embodiments, double-tippedneedles can be advantageous because they reduce the need to re-orientthe needle between stitches or steps in the suturing procedure.

FIG. 32 illustrates a block diagram of an example of a fully or mostlyautomated system 3200 with an automated fixture 3270 for holding andmanipulating/moving the target device (or suture target) and one or moreautomated fixtures configured for performing operations on the targetdevice. In the embodiment shown in FIG. 32, these additional automatedfixtures are configured as suturing arms 3280 (though other types orconfigurations of automated fixtures are also possible, e.g., forelectrospinning, other procedures, etc.). The fully automated system3200 is configured to execute one or more procedures or operations(e.g., suturing operations or other processing operations) for targetdevices, such as prosthetic heart valve implant devices for humansand/or other types of devices or components. In some embodiments, thesystem 3200 can be configured to suture an implant device without ahuman operator suturing any portion of the device. In variousimplementations, the system 3200 can be configured to perform a suturingprocedure with little (e.g., 1-10 times in a procedure, 1-10 times perday, or the like) or no intervention from a human operator.

The system 3200 includes a controller 3230 configured to direct one ormore components of the automated fixture assembly 3270 according to asuitable or pre-programmed process to manufacture an implant device. Thecontroller 3230 is also configured to direct one or more components ofthe suturing arm 3280 according to the process to manufacture theimplant device. The controller 3230 can also be configured tocommunicate with a targeting system 3260 configured to provide feedbackregarding the procedure or process (e.g., suturing procedure, etc.).Although illustrated as a separate component in the diagram of FIG. 32,the controller 3230 can be a component of the automated fixture assembly3270, the targeting system 3260, and/or the additional fixture orsuturing arm 3280. Similarly, the controller 3230 can be distributedamong two or more of the fixture assembly 3270, the targeting system3260, and/or the additional fixture/suturing arm 3280.

The exemplary controller 3230 includes one or more hardware and/orsoftware components designed to generate and/or to provide fixturecontrol signals (e.g., suture fixture control signals), fixture/suturingarm control signals, and/or data associated with one or more steps of asuturing process or other process. For example, the controller 3230 caninclude a computing device that has one or more processors 3232, as wellas one or more data storage devices or components 3234, which caninclude volatile and/or nonvolatile data storage media. In someembodiments, the data storage 3234 is configured to store process scriptdata (e.g., suture process script data), which can include dataindicating positioning of one or more components of the system 3200 forvarious steps and/or stages of the procedure (e.g., suturing process). Aprocedure can be represented at least in part by numeric or other datasets representing positioning information for one or more components ofthe automated fixture 3270, the fixture/suturing arm 3280, and/or one ormore additional components of the system 3200 for each respective stepor stage of the procedure. For example, a suturing process comprising aplurality of suturing steps can be represented at least in part bynumeric or other data sets representing positioning information for oneor more components of the automated suture fixture 3270, one or morecomponents of the suturing arm 3280, and/or one or more additionalcomponents of the system 3200 for each respective step or stage of thesuturing process.

The automated fixture assembly 3270 can include one or more componentsconfigured to articulate, to operate, and/or to position one or moremotorized actuators 3273 to manipulate a target holder 3271. This can bedone to present a target device (e.g., a heart valve, suture target,etc.) in a desirable or suitable position for executing at least part ofa procedure (e.g., suturing process) or an operation thereof inconjunction with the fixture/suturing arm 3280. In certain embodiments,the automated suture fixture 3270 includes a plurality of motorizedactuators 3273 that are mounted, attached, or connected to one anotherin a desirable configuration to provide a desirable range of motion forthe automated fixture 3270 for the purpose of articulating a targetdevice (e.g., an implant device) associated with or held by theautomated fixture 3270. In certain embodiments, the target holdercomponent 3271 can be associated with, or connected to, one or more ofthe motorized actuators 3273. Individual motorized actuators 3273 caninclude one or more rotating, translating, or otherwise articulatingmembers driven by a motor, a piston, or the like. Examples of automatedfixtures and associated components are described in greater detailherein with reference to FIGS. 10, 11, 18-25, 28-30, and 33-35.

The motorized actuators 3273 can be configured to provide a number ofdegrees of freedom of movement for the target holder 3271 and,consequently, a target device held by the target holder 3271. In someembodiments, the number of degrees of freedom is greater than or equalto 3, greater than or equal to 4, greater than or equal to 5, or greaterthan or equal to 6. The degrees of freedom can include positioning inany of the three spatial dimensions (e.g., movement in the x-axis,y-axis, and z-axis; horizontal movement, vertical movement, or acombination of horizontal and vertical movement), rotation (e.g.,rotation about the x-axis, about the y-axis, and/or about the z-axis),and/or rotation of the target holder 3271 around a longitudinal axis ofthe target device (e.g., keeping the position and pointing direction ofthe target device fixed while rotating the target device around itslongitudinal axis to expose a different portion of the target device tothe fixture/suturing arm 3280 and/or targeting system 3260).

The fixture/suturing arm 3280 can include one or more componentsconfigured to articulate, to operate, and/or to position one or moremotorized actuators 3283 to manipulate one or more processing-deviceholders 3281 (generally referred to herein as needle holders, thoughother processing devices beyond needles can be held). This can be doneto suture (e.g., perform one or more stitches) a target device (e.g., aheart valve or suture target) with a needle by performing anoutside-to-inside stitch and/or an inside-to-outside stitch according toa suturing process in conjunction with the automated suture fixture3270. In certain embodiments, the suturing arm 3280 includes a pluralityof motorized actuators 3283 that are mounted, attached, or connected toone another in a desirable configuration to provide a desirable range ofmotion for the suturing arm 3280 for the purpose of articulating aneedle held by the suturing arm 3280 or grabbing a needle held byanother suturing arm 3280 or by a needle transfer fixture 3290. Incertain embodiments, the needle holder 3281 can be associated with, orconnected to, one or more of the motorized actuators 3283. Individualmotorized actuators 3283 can include one or more rotating, translating,or otherwise articulating members driven by a motor, a piston, or thelike. Movement and operation of the suturing arm 3280 is similar to themovement and operation of the automated suture fixtures described ingreater detail herein.

The motorized actuators 3283 can be configured to provide a number ofdegrees of freedom of movement for the one or more needle holders 3281and, consequently, provide such freedom of movement to a needle held bya needle holder 3281. In some embodiments, the number of degrees offreedom is greater than or equal to 3, greater than or equal to 4,greater than or equal to 5, or greater than or equal to 6. The degreesof freedom can include positioning in any of the three spatialdimensions (e.g., movement in the x-axis, y-axis, and z-axis; horizontalmovement, vertical movement, or a combination of horizontal and verticalmovement), rotation (e.g., rotation about the x-axis, about the y-axis,and/or about the z-axis), and/or rotation of the needle holder 3281around a longitudinal axis of the needle (e.g., for thread managementpurposes).

It should be noted that the suturing arm 3280 can be a single suturingarm (e.g., a single multi-axis robotic arm) or it can be a plurality ofrobotic arms. In some embodiments, the suturing arm 3280 includesdual-coordinated, multi-axis robotic arms that are configured to passthe needle from one arm to the other when suturing the target device. Inaddition, the needle holder 3281 can be configured to operate withsingle-tipped and/or double-tipped needles.

The one or more needle holders 3281 can be configured to releasablysecure a needle to the suturing arm 3280. In some embodiments, at leastone needle holder 3281 includes gripping appendages that are configuredto open and close to alternately release and secure a needle. The needleholder 3281 can be rotated as well. This can be used to re-orient theneedle in the needle holder 3281 while the needle is being secured byanother suturing arm or another device or fixture (e.g., the needletransfer fixture 3290). The needle holder 3281 can include one or morefeatures configured to secure the needle in place during a suturingprocedure. For example, the needle holder(s) 3281 can include grippingelements configured to secure the needle in place as it is pushedthrough a fabric of the implant device. In some embodiments, one or moreof the needle holders 3281 can include an opening or aperture into whichthe needle can pass and then be secured (e.g., clamped, squeezed, etc.).In various embodiments, the needle holder(s) 3281 can include pliablematerial to secure the needle in the needle holder(s) 3281. The needleholder(s) 3281 can also implement electromagnetic components, adhesiveelements, components with high coefficients of friction, and the like tofacilitate securing of a needle during a suturing procedure.

In certain embodiments, the controller 3230 can provide control signalsfor directing the positioning of the motorized actuators 3273, 3283based on a suture process script. Coordination of the movement of themotorized actuators 3273, 3283 allows the automated suture fixture 3270and the suturing arm(s) 3280 to work in concert to manufacture theimplant device.

The system 3200 can include a targeting system 3260 that can beconfigured to provide feedback to the controller 3230 regarding theposition and orientation of the needle holder 3281 (and/or the needle),the target holder 3271 (and/or the target device), the automated fixture3270, and/or the suturing arm 3280. In some embodiments, the targetingsystem 3260 includes a camera or other imaging system, which can beconfigured to implement a variety of imaging capabilities for providingfeedback regarding the suturing procedure being executed by the system3200. The targeting system 3260 can include one or more imaging devicesor cameras, e.g., multiple imaging devices or cameras might be used toadd dimensions or depth to the images. The targeting system 3260 can beconfigured to generate images that can be analyzed by the controller3230 to determine whether sutures are correct and/or where to target theneedle for the next suture to be placed. In addition, the target system3260 can capture image data for quality control (e.g., similar to thatdescribed elsewhere herein) or other purposes at various stages of thesuturing procedure.

The controller 3230 can be configured to communicate with an optionaldisplay system 3250, such as an electronic computer display, or thelike. The display system 3250 can be used to provide information onquality control, manufacturing or process status, manufacturing orprocess progress, or other visual indications to allow humans to monitorperformance of the system 3200. In some embodiments, the display system3250 can be used to allow an operator to perform an inspection procedureusing the automated fixture 3270, as described herein. For example, anoperator can view enlarged imaging of the target device during or aftermanufacture to inspect the device. In certain embodiments, the automatedsystem 3200 can be configured to do automated quality control checks,for example, using inspection and/or recognition software (e.g., similarto facial-recognition software) as discussed above to identify or tohelp identify any quality control issues and/or whether the target hasthe required configuration after suturing or other processing.

In some implementations, the automated system 3200 can optionallyinclude a needle transfer fixture 3290 configured to secure a needlewhile the needle is not secured by a needle holder 3281. This can alloweach suturing arm 3280 to adjust its grip on the needle in betweenstitches of the suturing procedure. This can be used to ensure proper ortargeted alignment of the needle for the next stitch in the suturingprocedure. This can also be used to correct any misalignment of theneedle in the needle holder 3281 of a suturing arm 3280. For example, asuturing arm 3280 can use the needle transfer fixture 3290 to secure theneedle while the suturing arm 3280 changes its orientation inpreparation for the next stitch or step in the suturing procedure. Asanother example, a suturing arm 3280 can use the needle transfer fixture3290 to secure the needle to allow the suturing arm 3280 to adjust thegrip of the needle holder 3281 on the needle. The needle transferfixture 3290 can be configured for use with a single-tipped needleand/or a double-tipped needle.

In some embodiments, a needle may deflect while being secured by aneedle holder 3281 during a suturing procedure. Deflection of the needlecauses the needle to be in an unpredictable position after forming asuture (e.g., after passing from one suturing arm to another), resultingin difficulty in performing a subsequent suturing step. The needletransfer fixture 3290 allows the needle to be released from the suturingarm 3280 and secured in place while the suturing arm 3280 re-adjusts itsneedle holder 3281 to secure the needle in a desired location and/ororientation.

In some embodiments, the automated system 3200 is configured to performa suturing procedure with a standard needle (e.g., a single-tippedneedle). In such a procedure, a first suturing arm can be configured topass the needle through a material of the target device (e.g., from afirst side of the material to a second side such as from outside toinside the target device). Once the needle is at least partiallyinserted through the material of the target device, the first suturingarm can hand the needle off to the second suturing arm. After the secondsuturing arm receives the needle, it can pull the thread all the waythrough the material of the target device. The second suturing arm canthen rotate the needle 180 degrees and push the needle back through thefabric and/or frame of the target device. Once the needle is at leastpartially through the material of the target device, the second suturingarm can hand the needle back off to the first suturing arm, which thenpulls the needle the rest of the way through the fabric and rotates theneedle 180 degrees. This can be repeated as part of a suturingprocedure. In some embodiments, after the needle passes all the waythrough the fabric and/or the frame of the target device, the automatedfixture 3270 can rotate and/or translate position of the target deviceso that the needle passes through a different portion of the targetdevice to form the desired suture. In certain embodiments, the suturingarms 3280 adjust their position after the needle passes all the waythrough the fabric and/or frame of the target device so that the needlepasses through a different portion of the target device to form thedesired suture. In various embodiments, some combination of theautomated suture fixture 3270 and the suturing arms 3280 move after theneedle passes all the way through the fabric and/or frame of the targetdevice so that the needle passes through a different portion of thetarget device to form the desired suture.

In some embodiments, the automated system 3200 is configured to performa suturing procedure with a double-tipped needle. A difference betweenthe procedure with the standard needle and the double-tipped needle isthat once the second suturing arm grabs the needle and pulls it throughthe material of the target device, it does not need to rotate the needle180 degrees. Instead, the target device is rotated or moved, or thesecond suturing arm adjusts its position to the next position, and theneedle is pushed through the material of the target device. Thisprocedure may advantageously save time and can facilitate management ofthe thread.

In some embodiments, the suturing procedure is designed so that thesuturing arm 3280 performs the same stitch pattern each time while theautomated suture fixture 3270 moves the target device to the correctlocation for the next needle puncture location. An example of such aprocedure is illustrated in FIGS. 34A-34F using a double-tipped needle.In some embodiments, the suturing procedure is designed so that both thesuturing arm 3280 and the automated suture fixture 3270 move to performthe stitching. An example of such a procedure is illustrated in FIGS.35A-35H using a standard needle.

FIG. 33 illustrates an example embodiment of a fully automated suturingsystem 3300 with an automated suture fixture 3370 and two additionalautomated fixtures configured as suturing arms 3280 a, 3280 b. Theautomated suture fixture 3370 includes a target holder 3371 configuredto secure an implant device during suturing. The suturing arms includeneedle holders 3381 a, 3381 b to hold and transfer a needle duringsuturing. The automated suture fixture 3370 includes an articulating armconfigured to adjust a position and orientation of the target holder3371. Similarly, each of the suturing arms 3380 a, 3380 b includearticulating arms to adjust a position and orientation of theirrespective needle holders 3381 a, 3381 b. The needle holders 3381 a,3381 b can be configured to open and close to release and secure aneedle. The suturing arms 3380 a, 3380 b are mounted to a common base3382 that supports each suturing arm 3380 a, 3380 b.

FIGS. 34A-34F illustrate an exemplary suturing procedure (or portionthereof) using a double-tipped needle wherein the suturing procedureuses an automated suture fixture 3470 to move a target device 3410between stitches while the suturing arms 3280 a, 3280 b perform the samesuturing movements for each suture. In FIG. 34A, the automated suturefixture 3470 is illustrated securing the target device 3410 using atarget holder 3471. A first suturing arm 3480 a is illustrated securinga needle 3485 on an outside of the target device 3410. A second suturingarm 3480 b is illustrated with a portion inside the target device 3410,ready to receive the needle 3485 after it has been at least partiallypushed through the material of the target device 3410.

In FIG. 34B, the first suturing arm 3480 a has pushed the needle 3485partially through the material of the target device 3410 and the needleholder 3481 b of the second suturing arm 3480 b has gripped the needle3485. After the second needle holder 3481 b has gripped the needle 3485,the first needle holder 3481 a releases the needle 3485.

In FIG. 34C, the second suturing arm 3480 b pulls the needle 3485 intothe inside of the target device 3410. Once the needle 3485 is inside thetarget device 3410, the automated suture fixture 3470 rotates and/ormoves the target device 3410 into position for the next suture.

In FIG. 34D, the second suturing arm 3480 b pushes the needle 3485 backout of the target device 3410 (without rotating the needle 3485 becausethe needle 3485 is double-tipped). Once the needle 3485 is partiallypushed outside of the target device 3410, the first suturing arm 3480 agrips the needle 3485. After the first suturing arm 3480 a grips theneedle 3485, the second suturing arm releases the needle 3485.

In FIG. 34E, the first suturing arm 3480 a finishes pulling the needle3485 through the cloth of the target device 3410 so that the needle isagain outside of the target device 3410.

In FIG. 34F, the first suturing arm 3480 a pushes the needle into aneedle transfer fixture 3490 to allow the first suturing arm 3480 a toadjust its grip on the needle 3485. After re-gripping the needle 3485,the procedure repeats as described starting at FIG. 34A.

FIGS. 35A-35H illustrate an exemplary suturing procedure (or portionthereof) using a standard, single-tipped needle 3585 wherein thesuturing procedure uses an automated suture fixture 3570 to move atarget device 3510 and an automated suturing arm 3580 to form thetargeted sutures with the needle 3585. In FIG. 35A, the automated suturefixture 3570 secures the target device 3510. A first needle transferfixture 3590 a secures the needle 3585 that is partially penetratinginto the target device 3510. The suturing arm 3580 with a needle holder3581 approaches the target device 3510 to grab the needle 3585.

In FIG. 35B, the suturing arm 3580 secures the needle 3585. After thesuturing arm 3580 secures the needle 3585, the first needle transferfixture 3590 a releases the needle 3585.

In FIG. 35C, the suturing arm 3580 delivers the needle 3585 to a secondneedle transfer fixture 3590 b. The second needle transfer fixture 3590b secures the needle 3585 while the suturing arm 3580 repositions itselfto change the orientation of the needle 3585 relative to the needleholder 3581.

In FIG. 35D, the suturing arm 3580 grabs the needle 3585 with the neworientation and pushes the needle 3585 partially through the targetdevice 3510. Once the needle 3585 is partially inside the target device3510, the first needle transfer fixture 3590 a secures the needle 3585.After the needle 3585 is secured by the first needle transfer fixture3590 a, the suturing arm 3580 releases the needle 3585.

In FIG. 35E, the automated suture fixture 3570 moves relative to theneedle 3585 being secured by the first needle transfer fixture 3590 a topull the needle 3585 through the target device 3510.

In FIG. 35F, the suturing arm 3580 grabs the needle 3585, after whichthe first needle transfer fixture 3590 a releases it.

In FIG. 35G, the suturing arm 3580 delivers the needle 3585 to thesecond needle transfer fixture 3590 b. The second needle transferfixture 3590 b secures the needle 3585 while the suturing arm 3580repositions itself to change the orientation of the needle 3585 relativeto the needle holder 3581.

In FIG. 35H, the suturing arm 3580 delivers the needle 3585 to the firstneedle transfer fixture 3590 a whereupon it is secured by the firstneedle transfer fixture 3590 a and subsequently released by the suturingarm 3580. To finish the suture, the automated suture fixture 3570 canreturn to its position illustrated in FIG. 35A while the orientationand/or position of the target device 3510 has been changed relative tothe first needle transfer fixture 3590 a by the automated suture fixture3570. The process then repeats as described starting in FIG. 35A.

Multi-Tool Assistance

Certain embodiments disclosed herein provide for systems, devices, andmethods for assisting in suturing procedures or other procedures,wherein an automated fixture or automated suture fixture and/or othersystem components are utilized in order to allow for execution ofsuturing operations or other operations by an operator using a singlehand to operate, for example, a needle. In other words, in certainembodiments, the assist systems described herein may replace (or be usedinstead of) one of the operator's hands, thereby allowing the operatorto perform operations or sutures with only one hand. Where only a singlehand is required for executing suturing operations or other operations,systems, devices, and methods disclosed herein may allow for additionaloperations and functions to be performed by the operator using a freehand not required for holding the target or implant device being suturedor processed or operated on, which can advantageously instead be held byan articulation arm of the automated suture fixture, as describedherein. For example, the free hand of the operator may be utilized forpre-drilling, pre-punching, or pre-dimpling of fabric or material, orthe like, which may be executed using any suitable or desirable tool forsuch purposes, such as a mechanical tool, laser, or the like.

Furthermore, the free hand of the operator can be used for tensioningcontrol or other operations. The free hand of the operator can beutilized to operate any type of hand tool, such as hand tools requiringonly a simple trigger pull, for example. For example, a pistol-grippunch tool can be used by the operator with the operator's freehand.With the operator's free hand being used for other suture-relatedactivities, stitch quality can be improved, and the precision of variousoperations of a suturing procedure can be improved.

Additional Embodiments

Depending on the embodiment, certain acts, events, or functions of anyof the processes or algorithms described herein can be performed in adifferent sequence, may be added, merged, or left out altogether. Thus,in certain embodiments, not all described acts or events are necessaryfor the practice of the processes. Moreover, in certain embodiments,acts or events may be performed concurrently, e.g., throughmulti-threaded processing, interrupt processing, or via multipleprocessors or processor cores, rather than sequentially.

While many of the specific examples and embodiments described hereinfocus on suturing assist systems, automated suture fixtures, suturingoperations/steps/procedures, etc. the invention is not limited tosuturing applications and the same or similar systems, fixtures,devices, features, components, principles, operations/steps/procedures,etc. to those discussed with respect to suturing can be used for otheroperations/steps/procedures/treatments, etc. For example, the system maybe used to apply material to a frame using sputtering, electrospinning,rivets, staples, fasteners, fastener guns, clamps, or in other wayswithout involving suturing. While much of the discussion focuses onimplant devices (e.g., human prosthetic heart valve implants) or otherspecific examples, the same or similar systems, fixtures, devices,features, components, principles, operations/steps/procedures, etc. tothose discussed with respect to the examples above can be applied toother types of target devices.

Conditional language used herein, such as, among others, “can,” “could,”“might,” “may,” “e.g.,” and the like, unless specifically statedotherwise, or otherwise understood within the context as used, isintended in its ordinary sense and is generally intended to convey thatcertain embodiments do include, while other embodiments do not include,certain features, elements and/or steps. Thus, such conditional languageis not generally intended to imply that features, elements and/or stepsare in any way required for one or more embodiments or that one or moreembodiments necessarily include logic for deciding, with or withoutauthor input or prompting, whether these features, elements and/or stepsare included or are to be performed in any particular embodiment. Theterms “comprising,” “including,” “having,” and the like are synonymous,are used in their ordinary sense, and are used inclusively, in anopen-ended fashion, and do not exclude additional elements, features,acts, operations, and so forth. Also, the term “or” is used in itsinclusive sense (and not in its exclusive sense) so that when used, forexample, to connect a list of elements, the term “or” means one, some,or all of the elements in the list. Conjunctive language such as thephrase “at least one of X, Y and Z,” unless specifically statedotherwise, is understood with the context as used in general to conveythat an item, term, element, etc. may be either X, Y or Z. Thus, suchconjunctive language is not generally intended to imply that certainembodiments require at least one of X, at least one of Y and at leastone of Z to each be present.

It should be appreciated that in the above description of embodiments,various features are sometimes grouped together in a single embodiment,figure, or description thereof for the purpose of streamlining thedisclosure and aiding in the understanding of one or more of the variousinventive aspects. This method of disclosure, however, is not to beinterpreted as reflecting an intention that any claim require morefeatures than are expressly recited in that claim. Moreover, anycomponents, features, or steps illustrated and/or described in aparticular embodiment herein can be applied to or used with any otherembodiment(s). Further, no component, feature, step, or group ofcomponents, features, or steps are necessary or indispensable for eachembodiment. Thus, it is intended that the scope of the inventions hereindisclosed and claimed below should not be limited by the particularembodiments described above but should be determined only by a fairreading of the claims that follow.

The schematic flow chart diagrams included herein are generally setforth as logical flow chart diagrams. As such, the depicted order andlabeled steps are indicative of one embodiment of the presented method.Other steps and methods may be conceived that are equivalent infunction, logic, or effect to one or more steps, or portions thereof, ofthe illustrated method. Additionally, the format and symbols employedare provided to explain the logical steps of the method and areunderstood not to limit the scope of the method. Although various arrowtypes and line types may be employed in the flow chart diagrams, theyare understood not to limit the scope of the corresponding method.Indeed, some arrows or other connectors may be used to indicate only thelogical flow of the method. For instance, an arrow may indicate awaiting or monitoring period of unspecified duration between enumeratedsteps of the depicted method. Additionally, the order in which aparticular method occurs may or may not strictly adhere to the order ofthe corresponding steps shown.

Components, aspects, features, etc. of the systems, assemblies, devices,apparatuses, methods, etc. described herein may be implemented inhardware, software, or a combination of both. Where components, aspects,features, etc. of the systems, assemblies, devices, apparatuses,methods, etc. described herein are implemented in software, the softwaremay be stored in an executable format on one or more non-transitorymachine-readable mediums. Further, the software and related steps of themethods described above may be implemented in software as a set of dataand instructions. A machine-readable medium includes any mechanism thatprovides (e.g., stores and/or transports) information in a form readableby a machine (e.g., a computer). For example, a machine-readable mediumincludes read only memory (ROM); random access memory (RAM); magneticdisk storage media; optical storage media; flash memory devices; DVD's,electrical, optical, acoustical or other forms of propagated signals(e.g., carrier waves, infrared signals, digital signals, EPROMs,EEPROMs, FLASH, magnetic or optical cards, or any type of media suitablefor storing electronic instructions. Information representing the units,systems, and/or methods stored on the machine-readable medium may beused in the process of creating the units, systems, and/or methodsdescribed herein. Hardware used to implement the invention may includeintegrated circuits, microprocessors, FPGAs, digital signal controllers,stream processors, and/or other components.

What is claimed is:
 1. A fully automated system for forming sutures on atarget device, the system comprising: an automated suture fixturecomprising a target holder configured to maneuver the target devicesecured by the target holder; a first needle transfer fixture configuredto secure a needle during a first portion of a suturing procedure; asecond needle transfer fixture configured to secure the needle during athird portion of the suturing procedure; and an automated suturing armcomprising a needle holder configured to hold a needle during a secondportion of the suturing procedure, the automated suturing arm configuredto use the needle holder to take the needle from the first needletransfer fixture, to pass the needle to the second needle transferfixture, to take the needle from the second needle transfer fixture, andto pass the needle to the first needle transfer fixture.
 2. The systemof claim 1, wherein the automated suturing arm takes the needle from thesecond needle transfer fixture and passes the needle to the first needletransfer fixture through the target device as part of the suturingprocedure.
 3. The system of claim 1, wherein the automated suturefixture moves the target device toward the first needle transfer fixtureso that the needle held by the first needle transfer fixture passesthrough a portion of the target device as part of the suturingprocedure.
 4. The system of claim 3, wherein the automated suturefixture moves the target device away from the first needle transferfixture so that the needle held by the first needle transfer fixturepasses through a different portion of the target device as part of thesuturing procedure.
 5. The system of claim 1, wherein the needle holderof the automated suturing arm comprises gripping appendages that openand close to secure the needle.
 6. The system of claim 5, wherein thefirst needle transfer fixture comprises gripping appendages that openand close to secure the needle.
 7. The system of claim 1, wherein thefirst and second needle transfer fixtures are fixed in space and theautomated suture fixture and the automated suturing arm move relative tothe first and second needle transfer fixtures.
 8. The system of claim 1,wherein the needle is a single-tipped needle.
 9. The system of claim 1,wherein the first portion of the suturing procedure includes the firstneedle transfer fixture securing the needle while the automated suturingarm moves the target device towards the first needle transfer fixture sothat the needle penetrates the target device.
 10. The system of claim 9,wherein the second portion of the suturing procedure includes theautomated suturing arm taking the needle from the first needle transferfixture to pull the needle through the target device and to pass theneedle to the second needle transfer fixture.
 11. The system of claim10, wherein the third portion of the suturing procedure includes thesecond needle transfer fixture securing the needle while the automatedsuturing arm reorients itself.
 12. The system of claim 11, wherein afourth portion of the suturing procedure includes the automated suturingarm taking the needle from the second needle transfer fixture andpassing the needle through the target device to the first needletransfer fixture.
 13. The system of claim 12, wherein a fifth portion ofthe suturing procedure includes the automated suture fixture moving thetarget device away from the first needle transfer fixture to cause theneedle to pass through the target device.
 14. A fully automated systemcomprising: a first automated fixture comprising a plurality ofmotorized actuator devices and a target holder, the automated fixturebeing configured to maneuver a target device secured by the targetholder; a second automated fixture comprising a plurality of motorizedactuator devices and a first processing-device holder configured to holda processing device, the second automated fixture configured to maneuverthe processing device with the first processing-device holder to performan operation on the target device; and a third automated fixturecomprising a plurality of motorized actuator devices and a secondprocessing-device holder configured to hold the processing device, thethird automated fixture configured to maneuver the processing devicewith the second processing-device holder to perform a second operationon the target device.
 15. The system of claim 14, wherein the targetdevice is a heart valve.
 16. The system of claim 14, wherein theprocessing device is a needle for suturing the target device, the systemfurther comprising a needle transfer fixture configured to secure theneedle during a suturing procedure to allow the second automated fixtureto adjust an orientation of the needle relative to the firstprocessing-device holder.
 17. The system of claim 14, wherein the targetdevice holder is a gimbal holder assembly.
 18. The system of claim 17,wherein the gimbal holder assembly comprises a three-axis gimbal. 19.The system of claim 14, wherein the first automated suture fixture andthe second automated fixture each comprise a plurality of servo motordevices daisy-chained together.
 20. The system of claim 14, wherein thefirst automated fixture comprises an encoder associated with anarticulation arm, the encoder configured to provide position informationfor the articulation arm.